MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,04,05,07 report with the FDA on 2005-08-08 for ZIMMER PROV HEAD manufactured by Zimmer, Inc..
[386110]
During a reduction procedure, the femoral trail head came off and went inside the pelvis. This required open removal of the trail head from inside the pelvic region.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1822565-2005-00159 |
| MDR Report Key | 625303 |
| Report Source | 02,04,05,07 |
| Date Received | 2005-08-08 |
| Date of Report | 2005-07-05 |
| Date of Event | 2004-12-17 |
| Date Facility Aware | 2005-07-05 |
| Report Date | 2005-07-05 |
| Date Mfgr Received | 2005-07-12 |
| Date Added to Maude | 2005-08-11 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | CONNIE MORGAN |
| Manufacturer Street | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 5743724269 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZIMMER |
| Generic Name | PROVISIONAL FEMORAL HEAD UNNK |
| Product Code | JDD |
| Date Received | 2005-08-08 |
| Model Number | NA |
| Catalog Number | PROV HEAD |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 614931 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | P.O. BOX 708 WARSAW IN 465810708 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2005-08-08 |