FDA Adverse Event
Injury
Summary report: N
UNKNOWN
MDR report key: 3812297
·
Received May 15, 2014
Report
- Report Number
- 0001825034-2014-04055
- Event Type
- Injury
- Date Received
- May 15, 2014
- Date of Event
- April 21, 2014
- Report Date
- April 17, 2014
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- LPH
- PMA / PMN Number
- PUNKNOWN
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN; DATE IMPLANTED - UNKNOWN; PMA/510(K) NUMBER - UNKNOWN; MANUFACTURE DATE - UNKNOWN.
Description of Event or Problem · 1
IT WAS REPORTED A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE IN 1992. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO LINER WEAR. THE MODULAR HEAD AND LINER WERE REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 291751 | UNKNOWN | PROSTHESIS, HIP | LPH | BIOMET ORTHOPEDICS | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |