MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2012-06-20 for OXF PKS ANAT MEN BRG UHMWPE LT MED SZ 6 N/A 159550 manufactured by Biomet Uk Ltd..
[2767013]
It was reported that patient underwent primary knee procedure on (b)(6), 2012. Revision surgery was performed on (b)(6), 2012 due to dislocation. No further information was received.
Patient Sequence No: 1, Text Type: D, B5
[9926069]
The user facility is outside of the united states. No medwatch report was received. No product was returned. Current information is insufficient to permit a conclusion as to the cause of the event. No further complications have been reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002806535-2012-00155 |
| MDR Report Key | 2623102 |
| Report Source | 01,05,07 |
| Date Received | 2012-06-20 |
| Date of Report | 2012-05-25 |
| Date of Event | 2012-05-15 |
| Date Mfgr Received | 2012-05-25 |
| Device Manufacturer Date | 2011-02-09 |
| Date Added to Maude | 2012-06-20 |
| 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 | MR. PAUL AMES |
| Manufacturer Street | WATERTON INDUSTRIAL ESTATES |
| Manufacturer City | BRIDGEND, SOUTH WALES CF313XA |
| Manufacturer Country | UK |
| Manufacturer Postal | CF31 3XA |
| Manufacturer Phone | 0441656655 |
| Manufacturer G1 | BIOMET UK LTD. |
| Manufacturer Street | WATERTON INDUSTRIAL ESTATES |
| Manufacturer City | BRIDGEND, SOUTH WALES CF313XA |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CF31 3XA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXF PKS ANAT MEN BRG UHMWPE LT MED SZ 6 |
| Generic Name | OXFORD ANATOMIC BEARING |
| Product Code | DJR |
| Date Received | 2012-06-20 |
| Model Number | N/A |
| Catalog Number | 159550 |
| Lot Number | 2292671 |
| ID Number | N/A |
| Device Expiration Date | 2016-02-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET UK LTD. |
| Manufacturer Address | WATERTON INDUSTRIAL ESTATES BRIDGEND, SOUTH WALES CF313XA UK CF31 3XA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-06-20 |