MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2014-05-29 for PFC C/R FEM CEM RT SZ3 864162 manufactured by Depuy Orthopaedics, Inc..
[15326242]
Patient was revised to address poly wear of the insert and pain.
Patient Sequence No: 1, Text Type: D, B5
[15550549]
\ the investigation is ongoing. Depuy will notify the fda of the results of this investigation once it has been completed. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[28572649]
The device associated with this report was not returned. 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 lot code required was not provided. 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 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 | 1818910-2014-19719 |
| MDR Report Key | 3838865 |
| Report Source | 05,08 |
| Date Received | 2014-05-29 |
| Date of Report | 2014-05-05 |
| Date of Event | 2014-05-05 |
| Date Mfgr Received | 2014-06-16 |
| Date Added to Maude | 2014-05-29 |
| 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 | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PFC C/R FEM CEM RT SZ3 |
| Generic Name | KNEE FEMORAL COMPONENT |
| Product Code | HSA |
| Date Received | 2014-05-29 |
| Catalog Number | 864162 |
| 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 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-05-29 |