MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2005-12-20 for PFR 12.0MM X 175MM COCR 103180101 manufactured by Depuy Orthopaedics, Inc..
[408130]
Pt was revised due to fracture of the femoral stem. Pt has suffered (2) minor falls.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2005-02685 |
| MDR Report Key | 654815 |
| Report Source | 05,08 |
| Date Received | 2005-12-20 |
| Date of Report | 2005-11-22 |
| Date of Event | 2005-11-22 |
| Date Facility Aware | 2005-11-22 |
| Report Date | 2005-11-22 |
| Date Mfgr Received | 2005-11-22 |
| Date Added to Maude | 2005-12-22 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | GINNY STAMBERGER, MGR. |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 5743727333 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Street | 700 ORTHOPAEDICS DRIVE |
| Manufacturer City | WARSAW IN 46581098 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 0988 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PFR 12.0MM X 175MM COCR |
| Generic Name | TOTAL HIP REPLACEMENT |
| Product Code | JDD |
| Date Received | 2005-12-20 |
| Returned To Mfg | 2005-12-29 |
| Model Number | NA |
| Catalog Number | 103180101 |
| Lot Number | 374960008 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 644297 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Address | 700 ORTHOPAEDIC DR. WARSAW IN 465810988 US |
| Baseline Brand Name | PFR 12.0MM X 175MM COCR |
| Baseline Generic Name | FEMORAL STEM |
| Baseline Model No | NA |
| Baseline Catalog No | 103180101 |
| Baseline ID | NA |
| Baseline Device Family | PFR COCR |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-12-20 |