MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-03-21 for TIB BEARING COMP ROT/HIN KNEE 6475-3-933 manufactured by Stryker Orthopaedics Limerick.
[18275445]
It was reported that,? Pt presented with increased pain after a fall. The pt said she felt like things were loose. We replaced the above referenced parts. The parts that were removed were not excessively worn. Upon incision, there was a large evacuation of a hematoma. Dr (b)(6) decided to remove the 10 year old components referenced above and he did a synovectomy. There was some osteolysis noted on the medial proximal tibia. Both the femoral component and the tibial component were evaluated and were deemed to be stable.?
Patient Sequence No: 1, Text Type: D, B5
[18519324]
Additional information has been requested and if received, will be provided in a supplemental report. Catalog numbers and lot codes of other devices listed in this report: cat # 6475-3-940, lot # tdac210, description: krh standard axle. Cat # 6485-2-460, lot # tcpb233, description: krh duration bushing standard. Cat # 6485-2-460, lot # tcpb238, description: krh duration bushing standard. Cat # 6485-4-100, lot # tcpba50, description: krh duration standard bumper.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610726-2012-00091 |
| MDR Report Key | 2503696 |
| Report Source | 05,07 |
| Date Received | 2012-03-21 |
| Date of Report | 2012-03-12 |
| Date of Event | 2012-03-12 |
| Date Mfgr Received | 2012-03-12 |
| Device Manufacturer Date | 2002-01-01 |
| Date Added to Maude | 2012-03-27 |
| 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 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 | 2012-03-21 |
| Model Number | NA |
| Catalog Number | 6475-3-933 |
| Lot Number | KOGR |
| ID Number | 02017 |
| Device Expiration Date | 2007-01-31 |
| 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 LIMERICK |
| Manufacturer Address | LIMERICK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-03-21 |