MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2019-12-11 for UNKNOWN WRIST IMPLANT UNK WRIST manufactured by Depuy Orthopaedics Inc Us.
[185102897]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. No device was received. Root cause undetermined. Depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary. One wrist showed evidence of distal component loosening and middle finger metacarpal breaching. She has been listed for revision to a wrist fusion. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185102898]
The literature article entitled "management of the failed biaxial wrist replacement? , written by s. C. Talwalkar, et al, published in the journal of hand surgery vol. 30b, no. 3, june 2005; was reviewed. The purpose of the article was to report the clinical outcome of 10 patients in whom failure of a biaxial wrist replacement occurred and required revision surgery. Ten patients had revision surgery for failure of a biaxial wrist replacement (depuy). Six underwent a revision to a second biaxial wrist replacement, three had a wrist fusion and two were treated by excision arthroplasty. Nine of the patients were available for clinical review, with one patient dying from an unrelated cause. However, the case notes and prosthesis were available for review and analysis. Three of the patients had a wrist fusion due to lack of bone stock for implantation of a revision component. All of these had autologous bone grafting from the iliac crest, but the methods of fusion differed in that one had intramedullary pin fixation and the other two dorsal plate stabilization. Two patients had an excision arthroplasty which was considered necessary as the bone defect was too large for either a revision total joint arthroplasty or a fusion and both patients were unfit for a major procedure. The implant was removed, and the bone ends were debrided to smooth contours. Postoperatively the wrists were immobilized for 12 weeks to allow scarring to develop and provide soft tissue stability. All patients were assessed clinically and radiologically at a dedicated clinic. At assessment after revision surgery, none of the patients in this series had pain at rest or night pain, four had no pain and only six patients had a mean pain score of 4. 5. No intraoperative complications were noted during nine procedures. One patient who underwent a wrist fusion subsequently ruptured her extensor pollicis longus tendon which was treated successfully with a tendon transfer. One of the five patients who had their failed biaxial wrist implant revised to another biaxial wrist replacement die from unrelated causes and was, therefore, not available for follow-up. One wrist showed evidence of distal component loosening and middle finger metacarpal breaching. She has been listed for revision to a wrist fusion. This series demonstrates that distal component migration and loosening is the major cause of implant failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2019-119869 |
| MDR Report Key | 9451863 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2019-12-11 |
| Date of Report | 2019-11-18 |
| Date of Event | 2005-06-01 |
| Date Mfgr Received | 2019-11-18 |
| Date Added to Maude | 2019-12-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | JTE WARSAW MFG SITE |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN WRIST IMPLANT |
| Generic Name | WRIST IMPLANT |
| Product Code | JWJ |
| Date Received | 2019-12-11 |
| Catalog Number | UNK WRIST |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS INC US |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-12-11 |