MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-03-25 for RESTORIS ACETABULAR LINER 186136-54 manufactured by Pipeline Orthopedics Llc.
[20354251]
Patient was revised due to a wound infection. It was reported in the complaint that the infection was believed to be caused by changing of the leg wrap after surgery. During the revision, the acetabular liner was replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009701876-2013-00004 |
| MDR Report Key | 3030658 |
| Report Source | 05 |
| Date Received | 2013-03-25 |
| Date of Report | 2013-03-25 |
| Date of Event | 2013-02-25 |
| Date Mfgr Received | 2013-02-25 |
| Device Manufacturer Date | 2012-08-01 |
| Date Added to Maude | 2013-04-03 |
| 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 LAVELLE |
| Manufacturer Street | 3 WING DR SUITE 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 | 2013-03-25 |
| Model Number | 186136-54 |
| Catalog Number | 186136-54 |
| Lot Number | 190256-01 |
| Device Expiration Date | 2017-08-31 |
| 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 | 2013-03-25 |