FDA Adverse Event
Malfunction
Summary report: N
PRECIMED OFFSET ACETABULAR REA
MDR report key: 17151753
·
Received June 19, 2023
Report
- Report Number
- 0001822565-2023-01564
- Event Type
- Malfunction
- Date Received
- June 19, 2023
- Date of Event
- May 22, 2023
- Report Date
- July 20, 2023
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- HWX
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
(B)(4). THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Additional Manufacturer Narrative · 0
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
Additional Manufacturer Narrative · 0
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE OFFSET REAMER HANDLE FRACTURED AT THE ATTACHMENT TO THE DRILL. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Description of Event or Problem · 0
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Description of Event or Problem · 0
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1688000 | PRECIMED OFFSET ACETABULAR REA | INSTRUMENT, HIP | HWX | ZIMMER BIOMET, INC. | N/A | 5363607 | |
| 709514 | PRECIMED OFFSET ACETABULAR REA | INSTRUMENT, HIP | HWX | ZIMMER BIOMET, INC. | N/A | 5363607 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Female |