AVANTAGE CMNTD SHELL SS 44MM
Report
- Report Number
- 3002806535-2025-00277
- Event Type
- Injury
- Date Received
- July 22, 2025
- Date of Event
- July 3, 2025
- Report Date
- November 12, 2025
- Manufacturer
- BIOMET UK LTD.
- Product Code
- LZO
- UDI-DI
- 00887868524530
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). D-4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). D10: 3X UNKNOWN 5.0 MM LOCKING SCR: 1013-01-500XX, LOT UNKNOWN. 110031009, 28MM I.D. 38MM O.D. SIZE C BEARING, LOT 66508726. G2: FOREIGN ¿ AUSTRALIA. G-4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K121874. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D10, G3, G6, H2, H3, H6, H10, H11. THE FOLLOWING SECTIONS WERE CORRECTED: D6B - PRODUCT REMAINS IMPLANTED, H6 - HEALTH EFFECT - IMPACT CODE. D10: 1013-01-50030, 5.0 MM LOCKING SCR 30 MM STER, LOT L085. 1013-01-50028, 5.0 MM LOCKING SCR 28 MM STER, LOT L085. 1013-01-50034, 5.0 MM LOCKING SCR 34 MM STER, LOT L085. 1013-01-50030, 5.0 MM LOCKING SCR 30 MM STER, LOT L085. 1013-01-50030, 5.0 MM LOCKING SCR 30 MM STER, LOT J477. 1013-01-50030, 5.0 MM LOCKING SCR 30 MM STER, LOT J482. 1147-00-65045, 6.5X45MM CANC SCR THREAD. STER, LOT J156. 1013-01-50040, 5.0 MM LOCKING SCR 40 MM STER, LOT K470. 1020-02-75055, 7.5X55MM LOCK SELFTAP STER SCR, LOT J581. 1001-01-OSSIS, ACEOS NON-STER ACEOS (NO COATING), LOT 70541. 1005-01-OSSIS, ACEOS PLUG NON-STERILE, LOT 70541. THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. THE REVIEW IDENTIFIED THE FOLLOWING FINDINGS AND IMPRESSION. IMAGING FINDINGS: TWO CORONAL CT IMAGES WINDOWED TO BONE. DISLOCATED RIGHT TOTAL HIP ARTHROPLASTY. CABLE WIRE AROUND THE PROXIMAL FEMUR WHICH APPEARS WELL-FIXED. DUAL MOBILITY ACETABULAR CUP WITH CUSTOM PLATE IMPLANT APPEARS GROSSLY INTACT. FRANK LOOSENING OF THE ACETABULAR CUP WITH VERTICAL ORIENTATION AND MIGRATION OF THE CUP, DIASTASIS BETWEEN THE CUP AND SUPERIOR, MEDIAL, AND INFERIOR ACETABULAR WALL, AND RADIOLUCENCY AROUND THE INFERIOR ACETABULAR SCREW IN THE ISCHIUM. THERE IS A CHRONIC APPEARING DEFECT AND THINNING OF THE MEDIAL ACETABULAR WALL AND THE BONE DENSITY IS OVERALL DECREASED. FLUID/SOFT TISSUE DENSITY MATERIAL LATERAL TO THE GREATER TROCHANTER AND PROXIMAL FEMUR MAY REPRESENT A FLUID COLLECTION. CORTICATED BONE FRAGMENTS PROXIMAL TO THE GREATER TROCHANTER IN THE ATTENUATED DISTAL GLUTEAL TENDONS MAY INDICATE A CHRONIC OR ACUTE ON CHRONIC TEAR OF THE ABDUCTORS. IMPRESSION: CT IMAGES SHOW A DISLOCATED RIGHT TOTAL HIP ARTHROPLASTY WITH A CUSTOM ACETABULAR IMPLANT IN PLACE. ATTENUATION AND CHRONIC TEAR OF THE ABDUCTOR TENDONS CAN CONTRIBUTE TO HIP INSTABILITY. THERE IS GROSS LOOSENING AND MIGRATION OF THE ACETABULAR IMPLANT WITH LOOSENING OF THE INFERIOR ISCHIAL SCREW. ETIOLOGIC CONSIDERATIONS INCLUDE INSUFFICIENT BONE STOCK (RELATED TO OSTEOPOROSIS AND WHAT APPEARS TO BE A CHRONIC MEDIAL ACETABULAR WALL FRACTURE WITH BONE LOSS) AND INFECTION NOTING THE SUSPECTED FLUID COLLECTION NOTED AROUND THE PROXIMAL FEMUR. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, THE USE OF THE AVANTAGE CUP IN CONJUNCTION WITH AN OSSIS CUSTOM ACETABULAR PLATE, ALONG WITH EVIDENT LOOSENING OF THE PLATE AND THE IDENTIFIED PATIENT-SPECIFIC MEDICAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H1, H2, H11. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED THAT FIVE MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO A DISLOCATION OF BEARING AND CUP AND INFERIOR SCREWS LOOSE IN THE BONE. THREE SCREWS WERE REMOVED AND REPLACED. A LARGER HEAD WITH MORE OFFSET WAS PLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT APPROXIMATELY FIVE MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT RIGHT HIP REVISION DUE TO A DISLOCATION OF BEARING AND CUP AND INFERIOR SCREWS LOOSE IN THE BONE. THREE SCREWS WERE REMOVED. SCREW HOLES WERE CEMENTED AND LONGER SCREWS PUT IN AND LOCKED TO CAGE. THE CEMENTED LINER WAS TOO STUCK AND COULD NOT BE REMOVED. A LARGER HEAD WITH MORE OFFSET WAS PLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 802199 | AVANTAGE CMNTD SHELL SS 44MM | HIP PROTHESIS | LZO | BIOMET UK LTD. | 0001825836 | 00887868524530 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Female | Hospitalization| R | SEE H11 NARRATIVE. |