MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-03-28 for TIB BEARING COMP ROT/HIN KNEE 6475-3-933 manufactured by Stryker Orthopaedics Limerick.
[2599932]
It was reported that, "the x-ray revealed a broken tibial bearing component. "
Patient Sequence No: 1, Text Type: D, B5
[9704735]
When completed, the evaluation summary will be submitted in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 9610726-2012-00100 |
MDR Report Key | 2512377 |
Report Source | 05,07 |
Date Received | 2012-03-28 |
Date of Report | 2012-03-15 |
Date of Event | 2012-03-15 |
Date Mfgr Received | 2012-03-15 |
Device Manufacturer Date | 1996-07-18 |
Date Added to Maude | 2012-04-03 |
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 DR |
Manufacturer City | MAHWAH NJ 07430 |
Manufacturer Country | US |
Manufacturer Postal | 07430 |
Manufacturer Phone | 2018315000 |
Manufacturer G1 | STRYKER ORTHOPAEDICS LIMERICK |
Manufacturer Street | RAHEEN BUSINESS 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 | TIB BEARING COMP ROT/HIN KNEE |
Generic Name | IMPLANT |
Product Code | LGE |
Date Received | 2012-03-28 |
Model Number | NA |
Catalog Number | 6475-3-933 |
Lot Number | DVWWB |
ID Number | UNK |
Device Expiration Date | 2001-07-18 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
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 | 2012-03-28 |