MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-20 for HUMERAL CUP - 36MM DIA X 4MM THK 5570-3604 manufactured by Stryker Gmbh.
| Report Number | 0008031020-2020-00772 |
| MDR Report Key | 9862281 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2019-12-20 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-20 |
| 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. KEVIN SMITH |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS-MAHWAH |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUMERAL CUP - 36MM DIA X 4MM THK |
| Generic Name | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED |
| Product Code | KWS |
| Date Received | 2020-03-20 |
| Returned To Mfg | 2020-01-29 |
| Model Number | 5570-3604 |
| Catalog Number | 5570-3604 |
| Lot Number | 1H8NPV |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-20 |