MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2013-12-09 for PFC C/R FEM CEM LFT SZ5 864168 manufactured by 1219655 Depuy-raynham, A Div. Of Depuy Orthopaedic.
[11301473]
The device associated with this report was not returned. A complaint database search finds no other reported incidents against the provided product and lot combination. Requests for additional investigational inputs were made in accordance with (b)(4). No additional information was obtained. The investigation could not verify or identify any product contribution to the reported event with the information provided. Based on the inability to identify root cause, the need for corrective action was not indicated. Depuy considers the investigation closed at this time. Should the additional information be received, the investigation will be re-opened.
Patient Sequence No: 1, Text Type: N, H10
[16055102]
Patient was revised to address loosening of the femoral component and tibial tray at the cement/implant interface. Competitor cement was used at the time of original implantation.
Patient Sequence No: 1, Text Type: D, B5
[16576748]
This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. Compliant to part 803. 22, depuy orthopaedics is providing the following information, as depuy orthopaedics did not manufacture, or import, the following device(s): manufacturer: howmedica simplex bone cement event: this was used in conjunction with depuy product in this patient.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2013-35450 |
| MDR Report Key | 3506744 |
| Report Source | 05,08 |
| Date Received | 2013-12-09 |
| Date of Report | 2013-11-18 |
| Date of Event | 2013-11-18 |
| Date Mfgr Received | 2013-11-18 |
| Device Manufacturer Date | 1994-12-08 |
| Date Added to Maude | 2013-12-09 |
| 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 | 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC |
| Manufacturer Street | 325 PARAMOUNT DR. |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PFC C/R FEM CEM LFT SZ5 |
| Generic Name | FEMORAL KNEE PROSTHESIS |
| Product Code | HSA |
| Date Received | 2013-12-09 |
| Catalog Number | 864168 |
| Lot Number | 567CX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC |
| Manufacturer Address | 325 PARAMOUNT DR RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-12-09 |