FDA Adverse Event
Injury
Summary report: N
M2A MODULAR HEAD COMPONENT 32MM HEAD DIAMETER
MDR report key: 1960482
·
Received January 13, 2011
Report
- Report Number
- 1825034-2011-00040
- Event Type
- Injury
- Date Received
- January 13, 2011
- Report Date
- December 14, 2010
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- KWY
- PMA / PMN Number
- K003363
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER FOURTEEN STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN". DEVICE STILL IMPLANTED. THIS REPORT SUBMITTED (B)(6), 2011.
Description of Event or Problem · 1
PATIENT REPORTED THAT SHE UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6), 2003. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN AND SAID THE HIP SQUEAKS LOUDLY AND GRINDS. THE PATIENT ALSO SAID THAT IT FEELS LIKE THE HIP SHIFTS SOMETIMES. DUE TO THESE REASONS, SHE RETURNED TO HER SURGEON. ACCORDING TO THE PATIENT, THE SURGEON RECOMMENDED REVISION DUE TO BONE LOSS. AS OF THIS DATE, NO REVISION SURGERY HAS OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | M2A MODULAR HEAD COMPONENT 32MM HEAD DIAMETER | PROSTHESIS, HIP | KWY | BIOMET ORTHOPEDICS | N/A | 242990 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |