FDA Adverse Event
Injury
Summary report: N
UNKNOWN HIP
MDR report key: 4092757
·
Received September 16, 2014
Report
- Report Number
- 0001825034-2014-07693
- Event Type
- Injury
- Date Received
- September 16, 2014
- Report Date
- August 22, 2014
- 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
- PATIENT FAMILY MEMBER OR FRIEND
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. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATH AS LIMITED INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY.
Description of Event or Problem · 1
IT WAS REPORTED FROM THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE IN 2003 ON AN UNKNOWN SIDE. SUBSEQUENTLY, PATIENT ALLEGES HEARING LOSS, CLICKING, ELEVATED METAL ION LEVELS, AND PSEUDOTUMORS. NO REVISION IS ALLEGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 571239 | UNKNOWN HIP | PROSTHESIS, HIP | KWA | BIOMET ORTHOPEDICS | N/A | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |