FDA Adverse Event
Injury
Summary report: N
UNKNOWN - M2A-38 CUP
MDR report key: 3103166
·
Received May 9, 2013
Report
- Report Number
- 0001825034-2013-01359
- Event Type
- Injury
- Date Received
- May 9, 2013
- Date of Event
- August 3, 2009
- Report Date
- April 11, 2013
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- KWA
- PMA / PMN Number
- PN/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT ENROLLED IN CLINICAL STUDY, UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. A SUBSEQUENT REVISION OF THE CUP WAS PERFORMED ON (B)(6) 2010 DUE TO PAIN IN THE GROIN, THIGH, AND TROCK AS WELL AS OSTEOARTHRITIS, AND CUP MIGRATION. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2009 DUE TO ASCEPTIC LOOSENING OF THE ACETABULAR CUP. THE ACETABULAR CUP WAS REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 203893 | UNKNOWN - M2A-38 CUP | PROSTHESIS, HIP | KWA | BIOMET ORTHOPEDICS | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Hospitalization| R |