MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2011-03-07 for PLUS manufactured by Smith & Nephew Orthopaedics Aarau Switzerland.
[1717807]
Revision surgery was reported due to fracture of the ceramic ball head seven years post implantation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9613369-2011-00011 |
| MDR Report Key | 2009282 |
| Report Source | 01,07 |
| Date Received | 2011-03-07 |
| Date of Report | 2011-03-07 |
| Date of Event | 2011-02-04 |
| Date Mfgr Received | 2011-02-21 |
| Date Added to Maude | 2011-03-08 |
| 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 | 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 | CERAMIC BALL HEAD |
| Product Code | LPF |
| Date Received | 2011-03-07 |
| 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 ORTHOPAEDICS AARAU SWITZERLAND |
| Manufacturer Address | SCHACHENALLEE 29 AARAU SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2011-03-07 |