MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a *,07 report with the FDA on 2011-04-18 for PLUS ED75004169 manufactured by Smith & Nephew, Inc. Aarau Switzerland.
[1857418]
It was reported that revision surgery was performed due to pain and fracture of the device.
Patient Sequence No: 1, Text Type: D, B5
[9241440]
Based on the investigation performed at (b)(4) the root cause of the reported breakage of the ceramic ball head after more than ten years in situ could not be estabilshed conclusively. With respect to the time of function of the implant it is believed that no implant related factors contributed to the breakage.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9613369-2011-00020 |
| MDR Report Key | 2061111 |
| Report Source | *,07 |
| Date Received | 2011-04-18 |
| Date of Report | 2011-03-03 |
| Date of Event | 2011-02-28 |
| Date Mfgr Received | 2011-03-03 |
| Date Added to Maude | 2011-06-01 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS MELANIE TRAVIS |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013996233 |
| Manufacturer G1 | AARAU SWITZERLAND MANUFACTURING SITE |
| Manufacturer Street | SCHACHENALLEE 29 |
| Manufacturer City | AARAU |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLUS |
| Generic Name | FEMORAL HEAD |
| Product Code | LPF |
| Date Received | 2011-04-18 |
| Model Number | ED75004169 |
| Catalog Number | ED75004169 |
| Lot Number | 9912.15.3235 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. AARAU SWITZERLAND |
| Manufacturer Address | SCHACHENALLEE 29 AARAU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2011-04-18 |