BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH
Report
- Report Number
- 0001822565-2025-02951
- Event Type
- Injury
- Date Received
- August 15, 2025
- Date of Event
- January 25, 2013
- Report Date
- August 14, 2025
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- LPH
- PMA / PMN Number
- K934765
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). D10: 00631005836 XLPE 10 DEG POLY LINER 58X36 UNK, 00620205820 SHELL POROUS WITH MULTI HOLES 58 MM UNKNOWN, 00662406535 BONE SCREW SELF-TAPPING 35 MM LENGTH 6.5 MM DIA. UNKNOWN, 00662406535 BONE SCREW SELF-TAPPING 35 MM LENGTH 6.5 MM DIA. UNKNOWN, 00625006520 BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM LENGTH UNKNOWN, 00625006520 BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM LENGTH UNKNOWN, 00489405010 50MM X 10MM THICKNESS ACETABULAR AUGMENT UNKNOWN, 00625006525 BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH UNKNOWN, 00625006525 BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH UNKNOWN. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS; LOT IDENTIFICATION WAS NOT PROVIDED. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY AND IT WAS DETERMINED THAT THE ZB IMPLANTS USED ARE NOT COMPATIBLE WITH THE EXACTECH IMPLANTS USED: 142-36-00 COCR FEM HEAD 36MM +0 OFFSET (B)(6) 2014, 160-70-15 - NV CEMENTED PLUS STD SIZE 15, PC-17 - STEM CENTRALIZER 17MM AND 652-00-10 - OPTECURE WITH CCC - 10CC. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IT WAS IDENTIFIED THAT ZIMMER BIOMET DEVICES WERE IMPLANTED WITH COMPETITOR COMPONENTS. ZIMMER BIOMET HAS NOT CONFIRMED THE COMPATIBILITY FOR THESE COMBINATIONS OF DEVICES. IT IS UNKNOWN IF THESE OFF-LABEL USAGES MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS. PLEASE NOTE, PER THE IFUS: "DUE TO THE ACQUISITION OF PRE-EXISTING PRODUCT LINES, ZIMMER BIOMET HAS INITIATED A TESTING PROGRAM TO EVALUATE THE COMPATIBILITY OF THESE DEVICES WITH IMPLANTS AND COMPONENTS MADE OR DISTRIBUTED BY ALL ZIMMER BIOMET OR ITS AFFILIATES, WHICH INCLUDE ZIMMER GMBH (PREVIOUSLY CENTERPULSE ORTHOPEDICS LTD.), ZIMMER TRABECULAR METAL TECHNOLOGY, INC. (PREVIOUSLY IMPLEX CORP.), ZIMMER U.K. LTD., ZIMMER AUSTIN, INC. (PREVIOUSLY CENTERPULSE ORTHOPEDICS, INC.) AND BIOMET ORTHOPEDIC COMPANIES. ONLY AUTHORIZED COMBINATIONS SHOULD BE USED. DO NOT USE COMPONENTS OF THE TRABECULAR METAL ACETABULAR REVISION SYSTEM (TMARS) WITH COMPONENTS OF ANY OTHER SYSTEM OR MANUFACTURER UNLESS AUTHORIZED BY ZIMMER BIOMET. THIS COMPLAINT CANNOT BE CONFIRMED. 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 TRENDS.
IT WAS REPORTED THAT THE PATIENT IS NOT A GOOD HISTORIAN, AND STATES THAT THE PATIENT¿S HIP DISLOCATED AND ATTEMPTS WERE MADE BY ANOTHER DOCTOR, AND IT FAILED TO BE REDUCED. THE PATIENT WAS IN THE HOSPITAL FOR SEPSIS OF THE KIDNEYS AND GI TRACT WITH ERYTHEMA ABOUT THE LEFT HIP. A REDUCTION WAS ATTEMPTED AGAIN BY A DOCTOR; THIS AGAIN WAS WITHOUT SUCCESS AND AN ASPIRATION WAS COMPLETED. IT WAS FOUND THE PATIENT HAD BETA STREP FROM OTHER SOURCES. IT WAS DECIDED THAT THE THA SHOULD BE REMOVED BY THE PI OF THE STUDY. THE DEVICE WAS THEN REMOVED ALONG WITH ALL SURGICAL IMPLANT MATERIALS, NO DEVICE(S) WERE IMPLANTED IN PLACE OF THE EXPLANTED ORIGINAL DEVICES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2687906 | BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH | PROSTHESIS, HIPS | LPH | ZIMMER BIOMET, INC. | N/A | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization| R | SEE H11 NARRATIVE |