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 2015-12-16 for UNKNOWN DUAL GEOMETRY CUP UNK_REC manufactured by Stryker Orthopaedics-mahwah.
[33647959]
An evaluation of the device cannot be performed as the device was not returned to the manufacturer. Additional information has been requested and if received, will be provided in the supplemental report. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[33647960]
Left hip revision for poly wear and osteolysis. Cup, screws, insert, and head were revised. No corrosion noted on taper.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2015-04273 |
| MDR Report Key | 5302801 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2015-12-16 |
| Date of Report | 2015-11-19 |
| Date of Event | 2015-11-19 |
| Date Mfgr Received | 2015-11-19 |
| Date Added to Maude | 2015-12-16 |
| 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 | MS. RITA INTORRELLA |
| 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 | UNKNOWN DUAL GEOMETRY CUP |
| Generic Name | HIP IMPLANT |
| Product Code | KWB |
| Date Received | 2015-12-16 |
| Catalog Number | UNK_REC |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2015-12-16 |