MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-03-02 for SHORT TIBIA BEARING COMPONENT 6485-8-435 manufactured by Stryker Orthopaedics Limerick.
[1913353]
It was reported that, "pt complained of instability and pain. X-ray revealed a broken bearing component.
Patient Sequence No: 1, Text Type: D, B5
[9164360]
When completed, the evaluation summary will be submitted in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610726-2011-00056 |
| MDR Report Key | 2015700 |
| Report Source | 07 |
| Date Received | 2011-03-02 |
| Date of Report | 2011-02-11 |
| Date of Event | 2011-02-01 |
| Date Mfgr Received | 2011-02-11 |
| Device Manufacturer Date | 2000-03-13 |
| Date Added to Maude | 2011-03-15 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | 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 LIMERICK |
| Manufacturer Street | RAHEEN BUSNIESS PARK |
| Manufacturer City | LIMERICK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHORT TIBIA BEARING COMPONENT |
| Generic Name | IMPLANT |
| Product Code | LGE |
| Date Received | 2011-03-02 |
| Returned To Mfg | 2011-02-25 |
| Model Number | NA |
| Catalog Number | 6485-8-435 |
| Lot Number | GOXKC |
| ID Number | 0006EM1 |
| Device Expiration Date | 2005-03-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOPAEDICS LIMERICK |
| Manufacturer Address | LIMERICK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-03-02 |