MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-30 for ARCOM 32MM RNGLOC LNR 10DEG23 11-105933 manufactured by Biomet.
[17336705]
Patient had surgery for concerns with past hip replacement. During surgery, it was found that the acetabular liner was broken/fractured. The liner was replaced with a new liner. There was concern that the liner was defective.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5041908 |
| MDR Report Key | 4664987 |
| Date Received | 2015-03-30 |
| Date of Report | 2015-03-30 |
| Date of Event | 2014-12-05 |
| Date Added to Maude | 2015-04-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCOM 32MM RNGLOC LNR 10DEG23 |
| Generic Name | ACETABULAR LINER |
| Product Code | KWB |
| Date Received | 2015-03-30 |
| Model Number | 11-105933 |
| Lot Number | 975230 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET |
| Manufacturer Address | WARSAW IN 46581 US 46581 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-03-30 |