MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-13 for UNKNOWN REMOTION WRIST CARPAL SCREW IMPLANT UNK_SEL manufactured by Stryker Gmbh.
[138642603]
(b)(4). Report source, foreign - event occurred in the (b)(6). Concomitant medical products: medical product: exceed abt e1 muller cup 36x58, catalog #: ep-123658, lot #: 2135460; medical product: 36mm cocr mod hd std, catalog #: 11-363662, lot #: 266170. Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00271, 0001825034 -2019 -01089. Reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) was reviewed and no discrepancies were found. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[138642604]
The manufacturer became aware of a study from private hospital (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 lysis. 20 out of 22 cases.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008031020-2019-00272 |
| MDR Report Key | 8415713 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-13 |
| Date of Report | 2019-03-13 |
| Date of Event | 2009-01-01 |
| Date Mfgr Received | 2019-02-26 |
| Date Added to Maude | 2019-03-13 |
| 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. KEVIN SMITH |
| 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 SCREW IMPLANT |
| Generic Name | IMPLANT |
| Product Code | JWJ |
| Date Received | 2019-03-13 |
| Catalog Number | UNK_SEL |
| 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. Other | 2019-03-13 |