MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-30 for HIP INSTRUMENT 803-05-137 manufactured by Encore Medical L.p..
[146660684]
Instrument failure - while inserting acetabular cup, the thread broke off of the inserter. Some thread were left inside the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644408-2019-00472 |
| MDR Report Key | 8655724 |
| Date Received | 2019-05-30 |
| Date of Report | 2019-07-29 |
| Date of Event | 2019-04-30 |
| Date Mfgr Received | 2019-07-01 |
| Device Manufacturer Date | 2016-08-16 |
| Date Added to Maude | 2019-05-30 |
| 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 | TEFFANY HUTTO |
| Manufacturer Street | 9800 METRIC BLVD |
| Manufacturer City | AUSTIN TX 787585445 |
| Manufacturer Country | US |
| Manufacturer Postal | 787585445 |
| Manufacturer G1 | ENCORE MEDICAL L.P. |
| Manufacturer Street | 9800 METRIC BLVD |
| Manufacturer City | AUSTIN TX 787585445 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 787585445 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HIP INSTRUMENT |
| Generic Name | POSITIONER, FMP ACET |
| Product Code | HAO |
| Date Received | 2019-05-30 |
| Catalog Number | 803-05-137 |
| Lot Number | 197720L01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENCORE MEDICAL L.P. |
| Manufacturer Address | 9800 METRIC BLVD AUSTIN TX 787585445 US 787585445 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-30 |