FDA Adverse Event
Injury
Summary report: N
EXTRACTOR
MDR report key: 18650278
·
Received February 5, 2024
Report
- Report Number
- MW5151077
- Event Type
- Injury
- Date Received
- February 5, 2024
- Report Date
- February 1, 2024
- Manufacturer
- ZIMMER BIOMET
- Product Code
- HWB
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
- Health Professional
- *
Narratives
Description of Event or Problem · 0
WIFE, (B)(6) HAD SHOULDER REPLACEMENT. GOT INFECTION AND HARDWARE HAD TO BE REMOVED. DURING SURGERY THE IMPLANT PULLER BROKE AND HAD TO BE STITCHED BACK UP AND ANOTHER SURGERY SCHEDULED TO FINISH REMOVING HARDWARE. IN MEANTIME COULDN'T BE ON RA(RHEUMATOID ARTHRITIS) MEDICINE CAUSING HIGH ARTHRITIS. ALSO ANOTHER SURGERY. BIOMET BEEN LOOKING INTO IT FOR 3 MONTHS NOW. I RECOMMEND ANOTHER OFF SITE FACILITY TO INVESTIGATE.
Description of Event or Problem · 0
ADDITIONAL INFORMATION RECEIVED ON 2/6/2024 FOR REPORT MW5151077 TO UPDATE PROCODE.
Description of Event or Problem · 0
ADDITIONAL INFORMATION RECEIVED ON 2/6/2024 FOR REPORT MW5151077 TO CHANGE PROCODE TO HWB.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2031655 | EXTRACTOR | EXTRACTOR | HWB | ZIMMER BIOMET |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |