FDA Adverse Event
Other
Summary report: N
TAPERLOC FEMORAL RASP PROVISIONAL
MDR report key: 863990
·
Received June 11, 2007
Report
- Report Number
- 1825034-2007-00073
- Event Type
- Other
- Date Received
- June 11, 2007
- Date of Event
- May 9, 2007
- Report Date
- May 21, 2007
- Manufacturer
- BIOMET, INC.
- Product Code
- HTR
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. EVALUATION OF RETURNED DEVICE FOUND EVIDENCE OF FRACTURE DUE TO BENDING OVERLOAD. THIS REPORT FILED ON JUNE 11, 2007.
Description of Event or Problem · 1
IT WAS REPORTED THAT PT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY IN 2007. TIP SECTION OF RASP FRACTURED IN PT'S INTERMEDULLARY CANAL AND WAS NOTED ON POST-OPERATIVE RADIOGRAPHS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TAPERLOC FEMORAL RASP PROVISIONAL | HTR | BIOMET, INC. | NA | 385100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Other| S |