FDA Adverse Event
Injury
Summary report: N
ENDO II TAPER INSERT
MDR report key: 6395718
·
Received March 10, 2017
Report
- Report Number
- 0001825034-2017-01481
- Event Type
- Injury
- Date Received
- March 10, 2017
- Date of Event
- February 16, 2017
- Report Date
- June 16, 2017
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- KWL
- PMA / PMN Number
- PK984028
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. (B)(4).
Additional Manufacturer Narrative · 1
THIS FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Additional Manufacturer Narrative · 1
THIS FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS- PART: 12-162609 NAME: COCR INTEGRAL CENTRALIZER LOT: 204490, PART: 12-139012 NAME: ENDO II MOD HEAD LOT:? 730590, PART: 162656 NAME: INGLE ANSR IMPCT DSTL PSTNR LOT: 628330.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PATIENT'S HIP ARTHROPLASTY WAS REVISED DUE TO PAIN. THE HEAD, LINER AND CUP WERE REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE DUE TO PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 177555 | ENDO II TAPER INSERT | PROSTHESIS, HIP | KWL | BIOMET ORTHOPEDICS | N/A | 607230 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |