MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2012-10-11 for UNKNOWN DEPUY ADAPTER manufactured by .
[3040901]
Patient was revised to address poly wear and loosening of the femoral component at the cement/implant interface. The manufacturer of the cement used at the time of implantation is unknown.
Patient Sequence No: 1, Text Type: D, B5
[10208803]
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
[10540280]
The devices associated with this report were not returned. Review of the device history records and/or a complaint database search was not possible as the product information required was not provided. Requests for additional investigational inputs were made in accordance with (b)(4) appendix a; rev. C. No additional information was obtained. The investigation could not draw any conclusions regarding the reported event with the information available. Based on the inability to identify a root cause, 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 | 1818910-2012-23568 |
| MDR Report Key | 2781949 |
| Report Source | 05,08 |
| Date Received | 2012-10-11 |
| Date of Report | 2012-10-03 |
| Date of Event | 2012-10-03 |
| Date Mfgr Received | 2012-10-03 |
| Date Added to Maude | 2012-10-11 |
| 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 | DONALD DION JR. |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN DEPUY ADAPTER |
| Generic Name | FEMORAL KNEE PROSTHESIS |
| Product Code | LYT |
| Date Received | 2012-10-11 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-10-11 |