MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-08 for UNKNOWN REMOTION WRIST CARPAL BALL IMPLANT UNK_SEL manufactured by Stryker Gmbh.
[138271523]
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device disposition unknown.
Patient Sequence No: 1, Text Type: N, H10
[138271524]
The manufacturer became aware of a study from private (b)(6). The title of this study is? What we know after a decade of total wrist prostheses? And is associated with the remotion total wrist system. Within that publication, post-operative complications/ adverse events were reported, which occurred between 2009 and 2015. It was not possible to ascertain specific device catalogs from the report, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 30 complaints were initiated retrospectively for different adverse events mentioned in the report. This product inquiry addresses revision due to osteolysis. 3 out of 5 cases.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008031020-2019-00173 |
| MDR Report Key | 8404616 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-08 |
| Date of Report | 2019-03-08 |
| Date of Event | 2009-01-01 |
| Date Mfgr Received | 2019-02-26 |
| Date Added to Maude | 2019-03-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ROSE HAAS |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER GMBH |
| Manufacturer Street | BOHNACKERWEG 1 POSTFACH |
| Manufacturer City | SELZACH 2545 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 2545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN REMOTION WRIST CARPAL BALL IMPLANT |
| Generic Name | IMPLANT |
| Product Code | KWO |
| Date Received | 2019-03-08 |
| Catalog Number | UNK_SEL |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER GMBH |
| Manufacturer Address | BOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-08 |