MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-03-22 for CERAMIC LINER UNKNOWN manufactured by Depuy Warsaw.
[2572884]
Revision due to dislocation. Open reduction with delta ceramic head change and removed head had discoloration from certain areas.
Patient Sequence No: 1, Text Type: D, B5
[9768431]
This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.
Patient Sequence No: 1, Text Type: N, H10
[10222187]
Examination of the returned device by the supplier confirms the damage. The density of the ball head was analysed and found to be according to the valid specification. The microstructure of the ball head as obtained from the quality documents accomplishes the requirements as specified at the time of production, too. Based on the available information there are no indications of any pre existing material defect. Secondary metal transfer as a result of contact with metal parts in consequence of the dislocation or during the surgery can be found. Primary metal transfer can be found on the bore surface of the ball head. The reported discolorations of the surface are local deposit of metal transfer. Based on the performed investigation, the need for corrective action was not indicated. Depuy considers the investigation closed at this time. Should the product and/or additional information be received, the investigation will be re-opened.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2012-06915 |
| MDR Report Key | 2499807 |
| Report Source | 01,05 |
| Date Received | 2012-03-22 |
| Date of Report | 2012-08-13 |
| Date of Event | 2012-02-06 |
| Date Mfgr Received | 2012-02-06 |
| Date Added to Maude | 2012-03-22 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KATHERINE SEPPA |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer G1 | DEPUY WARSAW |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CERAMIC LINER |
| Generic Name | HIP |
| Product Code | OVO |
| Date Received | 2012-03-22 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY WARSAW |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-03-22 |