CUP POSITIONER
Report
- Report Number
- 0001822565-2024-00042
- Event Type
- Malfunction
- Date Received
- January 8, 2024
- Date of Event
- December 29, 2023
- Report Date
- April 9, 2024
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- LXH
- UDI-DI
- 00889024120136
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRODUCT WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.
(B)(4). D10: CAT# 00-8751-010-36 LOT# 65377036 CONTINUUM LONGEVITY NEUTRAL LINER, II 36 X 52 CAT# 00-6250-065-30 LOT # J7593913 BONE SCREW 6.5X30 SELFTAP CAT# 574101030 LOT# 3121808 AVENIR CMPL HA STD NC SIZE 3 CAT# 00-8775-036-01 LOT# 3171528 BIOLOX DELTA FEM HEAD, 36MM, -3.5MM CAT# 00875705202 LOT# 6613801552MM O.D. SIZE II POROUS UNCEMENTED WITH MULTIHOLES MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001822565-2024-00044 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTION WAS CORRECTED: LOT NUMBER. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. NO PRODUCT WAS RETURNED; HOWEVER, PICTURES WERE PROVIDED AND REVIEWED. AN EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THAT THE CUP POSITIONER WAS COVERED IN BIO-DEBRIS AND DETACHED FROM THE SHELL. THE PICTURES DID NOT CAPTURE THE THREADS ENOUGH FOR FURTHER REVIEW. PICTURES WERE NOT PROVIDED OF THE SHELL. NO FURTHER EVALUATION CAN BE MADE. MEDICAL RECORDS WERE NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. THE REPORTED ISSUE CANNOT BE CONFIRMED, AND A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
ADDITIONAL INFORMATION RECEIVED. IT WAS REPORTED THAT THE THREADS WERE NOT AN ISSUE. THE INNER SPRING WAS ALLOWING THE CUP TO SEAT BACK TOO FAR. NO ADDITIONAL INFORMATION WAS AVAILABLE.
IT WAS REPORTED THAT DURING SURGERY, THE CUP INSERTER WAS SCREWED INTO THE CUP BUT WOULD NOT RELEASE OR UNSCREW FROM THE CUP. THE CUP GOT STUCK IN THE FEMUR AND HAD TO BE PRIED OFF THE INSERTER WITH A CURETTE AND PLIERS. THE CUP WAS REMOVED FROM THE INSERTER. THERE WAS NO DAMAGE NOTED TO THE CUP, SO IT WAS IMPLANTED. THE INSERTER NEEDED TO BE REPLACED. IT WAS REPORTED THAT SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO PATIENT IMPACT OR INJURY. THERE WERE ALSO NO SURGICAL COMPLICATIONS, AND NO FOREIGN BODY RETAINED. NO ADDITIONAL INFORMATION.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 568389 | CUP POSITIONER | INSTRUMENT, HIP | LXH | ZIMMER BIOMET, INC. | N/A | 62641799 | 00889024120136 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |