This section describes safety outcomes from the published literature that the committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
5.1 Extensor carpi ulnaris (ECU) tendonitis was reported in 17% (6/35) and 20% (9/46) of wrists in 2 case series of 35 and 41 patients respectively. Additional surgery was needed by 1 patient who developed pain along the ECU tendon in a case series of 17 patients.
5.2 Infection was reported in 1 patient in the case series of 41 patients; the implant was removed and replaced after the infection had resolved. Minor soft tissue infection was reported in 6% (2/35) of patients in the case series of 35 patients.
5.3 Ectopic bone formation around the ulnar stem was reported in 7% (3/46) of patients in the case series of 41 patients. Ectopic bone formation was reported in 14% (5/35) of patients in the case series of 35 patients.
5.4 Osteophytes were reported in 9% (4/46) of joints in the case series of 41 patients; they developed within 2 years of the procedure and were removed from the distal ulnar stem.
5.5 Screw or cap loosening was reported in 1 patient in the case series of 35 patients. Loosening of the implant and pain was reported in 1 patient who had a first-generation implant in the case series of 17 patients; a revision was done with a second-generation implant. Aseptic ulnar component loosening, which needed revision surgery, was reported in 1 patient in a case series of 10 patients.
5.6 Debridement of prominent screw tips on the radial styloid was reported in 14% (2/14) of joints in a case series of 13 patients. A small surgical procedure to burr down the prominent ends of the screw tips was reported in 30% (3/10) of patients in the case series of 10 patients.
5.7 De Quervain's disease was reported in 1 patient in a case series of 9 patients; the patient needed further surgery 1 year after the distal radioulnar joint replacement. Transient carpal tunnel syndrome was reported in 1 patient in the same study. Median neuropathy was reported in 1 patient in the case series of 10 patients. Radial plate malposition, implant failure, and lunate-implant impingement were each reported in 1 patient in the case series of 41 patients.
5.8 In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers described the following anecdotal adverse event: the ulna stem breaking after high energy trauma. They considered that the following was a theoretical adverse event: the polyethylene ball component wearing out over time.
5.9 Four commentaries from patients who had experience of this procedure were received, which were discussed by the committee.