FDA Adverse Event
Injury
Summary report: N
MCLAUGHLIN +5 ACET 62MMX24L
MDR report key: 4211815
·
Received October 29, 2014
Report
- Report Number
- 0001825034-2014-08436
- Event Type
- Injury
- Date Received
- October 29, 2014
- Date of Event
- October 8, 2014
- Report Date
- October 8, 2014
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- KWA
- PMA / PMN Number
- PK050124
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY RELATED TO THE EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY IN 2006. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO UNKNOWN REASONS. THE CUP WAS REMOVED ALONG WITH AN UNKNOWN LINER AND A COMPETITOR HEAD AND REPLACED WITH COMPETITOR PRODUCTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 692419 | MCLAUGHLIN +5 ACET 62MMX24L | PROSTHESIS, HIP | KWA | BIOMET ORTHOPEDICS | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |