MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-07-18 for RESTORIS TOTAL HIP SYSTEM manufactured by Pipeline Orthopedics Llc.
[17929854]
Incision and drainage procedure conducted on pt approximately one month after total hip arthroplasty surgery. Pt subsequently treated with antibiotics. No components replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009701876-2013-00012 |
| MDR Report Key | 3251803 |
| Report Source | 05 |
| Date Received | 2013-07-18 |
| Date of Report | 2013-07-18 |
| Date of Event | 2013-06-20 |
| Date Mfgr Received | 2013-06-20 |
| Date Added to Maude | 2013-07-30 |
| 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 | 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 TOTAL HIP SYSTEM |
| Generic Name | OQH, LPH |
| Product Code | OQH |
| Date Received | 2013-07-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2013-07-18 |