MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2020-01-23 for 32X58-61MM 10 DEG HOOD INS 6283-7-581 manufactured by Stryker Orthopaedics-mahwah.
[176384094]
It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[176384095]
As reported: "acetabular poly insert swap. Normal wear observed by surgeon. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2020-00149 |
| MDR Report Key | 9623672 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-01-23 |
| Date of Report | 2020-03-26 |
| Date of Event | 2019-12-26 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-01-23 |
| 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. ALESSANDRA CHAVEZ |
| Manufacturer Street | 2555 DAVIE ROAD |
| Manufacturer City | FORT LAUDERDALE FL 33317 |
| Manufacturer Country | US |
| Manufacturer Postal | 33317 |
| Manufacturer Phone | 9546280700 |
| 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 | 32X58-61MM 10 DEG HOOD INS |
| Generic Name | PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR COMPONENT) |
| Product Code | JDL |
| Date Received | 2020-01-23 |
| Catalog Number | 6283-7-581 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOPAEDICS-MAHWAH |
| Manufacturer Address | 325 CORPORATE DRIVE MAHWAH NJ 07430 US 07430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-01-23 |