MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2013-06-28 for OXFORD MEDIUM SIZE 4/5MM TRIAL BEARING N/A 32-420378-2 manufactured by Biomet Uk Ltd..
[3555774]
It was reported that during the trial reduction portion of a surgery on an unknown date, the trial bearing snapped away from the metal rod and couldn't be removed. All implants had to be removed to free the bearing. The surgery was completed without further incident.
Patient Sequence No: 1, Text Type: D, B5
[10972994]
The user facility is outside of the united states. No medwatch report was received. Current information is insufficient to permit a conclusion as to the cause of the event. No further complications have been reported. No item or lot numbers were reported. Date of event - unknown. Manufacture date - unknown. Evaluation in process but not yet complete. Upon completion of evaluation, a follow up report will be sent to the fda.
Patient Sequence No: 1, Text Type: N, H10
[10981839]
Bearing was returned and evaluated. The product lot number identification necessary to review manufacturing history was not available. Dimensional check to the drawing found no deviations that would have resulted in the reported issue. Visual examination found marks and indents indicating the item had been used a number of times. Inspection of the returned item concluded the item probably fractured due to wear and tear.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002806535-2013-00118 |
| MDR Report Key | 3195114 |
| Report Source | 01,06,07 |
| Date Received | 2013-06-28 |
| Date of Report | 2013-06-07 |
| Date Mfgr Received | 2013-07-16 |
| Date Added to Maude | 2013-06-28 |
| 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 | MS. SIAN ROGERS |
| 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 | OXFORD MEDIUM SIZE 4/5MM TRIAL BEARING |
| Generic Name | PROSTHESIS ALIGNMENT |
| Product Code | IQO |
| Date Received | 2013-06-28 |
| Returned To Mfg | 2013-06-11 |
| Model Number | N/A |
| Catalog Number | 32-420378-2 |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2013-06-28 |