MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2013-10-22 for UNKNOWN DEPUY PATELLA UNK-KNEE manufactured by 1818910 Depuy Orthopaedics, Inc..
[3789192]
Patient was revised to address infection, poly wear and osteolysis. Loosening of the tibial and femoral component was also reported but was at the bone/cement interface. The cement manufacturer is unknown.
Patient Sequence No: 1, Text Type: D, B5
[11156167]
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
[11662761]
Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. The device associated with this reported event remains implanted. No revision surgery has been reported. Requests for additional investigational inputs were made in accordance with wi-7915 appendix a. No additional information was obtained. Review of the device history records and/or a lot specific complaint database search was not possible as the product and lot code required was not provided. The investigation could not draw any conclusions about the reported event based on the information provided. No evidence was found suggesting product error was a contributing factor and the need for corrective action was not indicated. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2013-31108 |
| MDR Report Key | 3421942 |
| Report Source | 05,08 |
| Date Received | 2013-10-22 |
| Date of Report | 2013-10-03 |
| Date of Event | 2013-10-03 |
| Date Mfgr Received | 2014-01-31 |
| Date Added to Maude | 2013-10-22 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | STACEY TRICK |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743714554 |
| Manufacturer G1 | 1818910 DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN DEPUY PATELLA |
| Generic Name | PATELLA |
| Product Code | HTG |
| Date Received | 2013-10-22 |
| Catalog Number | UNK-KNEE |
| 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 | 1818910 DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Address | 700 ORTHOPAEDIC DR. WARSAW IN 46581 US 46581 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-10-22 |