MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-08-23 for UNKNOWN MOOVIS CUP (PRESS-FIT OR SCREWED) UNK_SEL manufactured by Stryker Gmbh.
[156268677]
This complaint has been reported during a literature review performed by the post market surveillance group. No product identification is possible. Based on the investigation results, no definitive relation could be established between the product and the reported failure adverse consequence. The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information will be provided. If further relevant information becomes available, the investigation will be reevaluated and resubmitted accordingly. Device disposition is unknown.
Patient Sequence No: 1, Text Type: N, H10
[156268678]
The manufacturer became aware of a post-market clinical follow-up (pmcf) from (b)(6). The title of this report is? Prospective and a retrospective evaluation of the mid- to long-term outcomes of subjects treated with the moovistm prosthesis? Which is associated with the stryker moovis prosthesis. Within that publication, post- operative complications/ adverse events were reported which occurred between 2013 and 2016. It was not possible to ascertain specific device catalog or patient information 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 9 complaints were initiated retrospectively for different adverse events mentioned in the report. This product inquiry addresses neurodystrophy. 2 out of 4 cases. The pmcf report states,? 4 patients were diagnosed with neurodystrophy in post op, exhibiting moderate forms of this chronic pain syndrome. All the involved patients recovered from this neurodystrophty without significant sequelae.?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008031020-2019-01141 |
| MDR Report Key | 8925860 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-08-23 |
| Date of Report | 2019-08-23 |
| Date of Event | 2013-01-01 |
| Date Mfgr Received | 2019-08-01 |
| Date Added to Maude | 2019-08-23 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ANNA JUSINSKI |
| 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 MOOVIS CUP (PRESS-FIT OR SCREWED) |
| Generic Name | IMPLANT |
| Product Code | KYJ |
| Date Received | 2019-08-23 |
| 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. Other | 2019-08-23 |