FDA Adverse Event
Injury
Summary report: N
TPRLC 133 MP TYPE1 PPS HO 11.0
MDR report key: 4093280
·
Received September 16, 2014
Report
- Report Number
- 0001825034-2014-07719
- Event Type
- Injury
- Date Received
- September 16, 2014
- Date of Event
- November 20, 2013
- Report Date
- August 20, 2014
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- JDI
- PMA / PMN Number
- PK110400
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6), 2013. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6), 2013 DUE TO A PERIPROSTHETIC FRACTURE. THE SURGEON PERFORMED AN ORIF AND REPLACED THE HEAD AND STEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 571141 | TPRLC 133 MP TYPE1 PPS HO 11.0 | PROSTHESIS, HIP | JDI | BIOMET ORTHOPEDICS | N/A | 3016420 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Hospitalization| R |