ZIMMER TRILOGY LONGEVITY CROSSLINKED LINER
Report
- Report Number
- 0002648920-2016-00920
- Event Type
- Injury
- Date Received
- July 7, 2016
- Date of Event
- June 6, 2016
- Report Date
- April 19, 2023
- Manufacturer
- ZIMMER MANUFACTURING B.V.
- Product Code
- LPH
- PMA / PMN Number
- K990135
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: CAT#: 00620005022/LOT #: 60330424/ SHELL POROUS WITH CLUSTER HOLES. CAT #: 7711-06-20/LOT #: 60136227/ M/L TAPER STEM. CAT #: 6250-65-40/LOT # 60367519/SCREW. CAT #: 6250-65-30/LOT #: 60373634/SCREW. 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.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: AN INITIAL LEFT THA WAS PERFORMED ON DEC 1, 2005. A REVISION OCCURRED ON JUN 6, 2016 DUE TO RECURRENT ANTERIOR DISLOCATIONS. A TEAR WAS IDENTIFIED IN THE ANTERIOR CAPSULE WITH EVIDENCE OF LINER WEAR AND EDGE ROUNDING. THE HEAD AND LINER WERE REPLACED WITH NO COMPLICATIONS NOTED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: LEFT TOTAL HIP ARTHROPLASTY WITH UNDERSIZED ACETABULAR CUP AS COMPARED TO THE FEMORAL HEAD. INTERVAL DEVELOPMENT OF MULTIPLE WELL CORTICATED OSSIFIC DENSITIES ALONG THE LEFT GREATER TROCHANTER COULD INTERVAL PRIOR TRAUMA. AFTER DISCUSSION WITH A HCP, THE UNDERSIZED CUP WAS DETERMINED TO BE RELATED TO THE 36MM HEAD ON THE LINKED COMPLAINT. ROOT CAUSE REMAINS UNCHANGED. 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.
IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT HIP REVISION DUE TO RECURRENT ANTERIOR DISLOCATIONS APPROXIMATELY ELEVEN YEARS POST IMPLANTATION. DURING THE PROCEDURE, A TEAR WAS NOTED IN THE ANTERIOR CAPSULE WITH LINER WEAR AND EDGE ROUNDING AT THE SITE. THE CUP AND STEM WERE STABLE AND INTACT. THE HEAD AND LINER WERE REPLACED WITHOUT COMPLICATIONS.
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
ONE PHOTOGRAPH WHICH SHOWED THE EXPLANTS WAS PROVIDED. IDENTIFICATION NUMBER OF THE HEAD ARE VISIBLE. THE CUP SHOWS DAMAGE CONSISTENT WITH REMOVAL. NO OTHER ISSUES CAN BE IDENTIFIED FROM THE PHOTO. THIS DEVICE IS USED FOR TREATMENT. COMPATIBILITY CHECK SHOWED THAT PRODUCTS WERE COMPATIBLE. NO ISSUES WERE FOUND DURING THE COMPLAINT HISTORY REVIEW. OPERATIONAL NOTES WERE REVIEWED AND PROPER SURGICAL TECHNIQUE WAS FOLLOWED. ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE.
IT IS REPORTED THAT A PATIENTS LEFT HIP WAS REVISED DUE TO DISLOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 428836 | ZIMMER TRILOGY LONGEVITY CROSSLINKED LINER | HIP PROSTHESIS | LPH | ZIMMER MANUFACTURING B.V. | 60300869 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Female | Hospitalization| R |