MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2001-04-12 for FOUNDATION ACETABULAR INSRUMENT * 803-01-058 manufactured by Encore Orthopedics, Inc..
[224761]
User facility reported to fda that threads from acetabular inserter instrument had broken off in apex hole of acetabular shell. Surgeon attempted to remove all of the threads, but was not able to retract the small amount of threads.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644408-2001-00010 |
| MDR Report Key | 326955 |
| Report Source | 06 |
| Date Received | 2001-04-12 |
| Date of Report | 2001-04-01 |
| Date Added to Maude | 2001-04-18 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 9800 METRIC BLVD |
| Manufacturer City | AUSTIN TX 78758 |
| Manufacturer Country | US |
| Manufacturer Postal | 78758 |
| Manufacturer Phone | 8004568696 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FOUNDATION ACETABULAR INSRUMENT |
| Generic Name | HIP INSTRUMENT |
| Product Code | KOA |
| Date Received | 2001-04-12 |
| Model Number | * |
| Catalog Number | 803-01-058 |
| Lot Number | * |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 316362 |
| Manufacturer | ENCORE ORTHOPEDICS, INC. |
| Manufacturer Address | 9800 METRIC BLVD. AUSTIN TX 78758 US |
| Baseline Brand Name | FOUNDATION ACETABULAR INSTRUMENT |
| Baseline Generic Name | HIP INSTRUMENT |
| Baseline Catalog No | 803-01-058 |
| Baseline Device Family | FOUNDATION HIP SYSTEM |
| 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. Other | 2001-04-12 |