MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-04-26 for RESTORIS ACETABULAR LINER 186136-54 manufactured by Pipeline Orthopedics Llc.
[15269811]
As part of an incision and drainage revision procedure, the surgeon replaced the acetabular liner and femoral head components.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009701876-2013-00006 |
| MDR Report Key | 3084901 |
| Report Source | 05 |
| Date Received | 2013-04-26 |
| Date of Report | 2013-04-26 |
| Date of Event | 2013-03-27 |
| Date Mfgr Received | 2013-03-29 |
| Date Added to Maude | 2013-05-01 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SEAN LAVALLE |
| Manufacturer Street | 3 WING DR STE 102 |
| Manufacturer City | CEDAR KNOLLS NJ 07927 |
| Manufacturer Country | US |
| Manufacturer Postal | 07927 |
| Manufacturer Phone | 9732678800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESTORIS ACETABULAR LINER |
| Product Code | OQH |
| Date Received | 2013-04-26 |
| Model Number | 186136-54 |
| Catalog Number | 186136-54 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PIPELINE ORTHOPEDICS LLC |
| Manufacturer Address | CEDAR KNOLLS NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-04-26 |