BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH

    MDR report key: 23569569 · Received November 17, 2025

    Report

    Report Number
    0002648920-2025-00317
    Event Type
    Injury
    Date Received
    November 17, 2025
    Date of Event
    May 19, 2025
    Report Date
    April 20, 2026
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    UDI-DI
    00889024119826
    PMA / PMN Number
    K934765
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A5, A6, B4, B5, D4 (EXPIRATION DATE, UDI #), G3, G6, H2, H3, H6, H11. CORRECTED: H4. THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LACK OF PRODUCT/INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PATIENT HAD AN INITIAL LEFT THA WITH DEPUY IMPLANTS. PATIENT HAD A REVISION SURGERY. PATIENT REPORTED ICD CODING CORRESPONDING TO BROKEN INTERNAL LEFT HIP PROSTHESIS AS AN INDICATION FOR REVISION. THE DEPUY STEM WAS RETAINED, ALL OTHER COMPONENTS OF DEPUY (SHELL, LINER AND HEAD) WERE REVISED. ZIMMER BIOMET G7 SHELL, LINER, BEARING AND SCREWS WERE IMPLANTED, ALONG WITH A DEPUY BIOLOX HEAD. NO OPERATIVE NOTES PROVIDED OF THE INITIAL OR REVISION SURGERY. PATIENT REPORTED VIA A PHONE CALL TO ZB REPRESENTATIVE THAT THEY RECEIVED MIXED IMPLANTS WITH ZB AND DEPUY COMPONENTS. THE PATIENT HAS SIGNIFICANT NERVE DAMAGE POST-OP. NO MEDICAL RECORDS PROVIDED RELATED TO THE ISSUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. HOWEVER, AN OFF-LABEL USE WAS IDENTIFIED AS ZB IMPLANTS WERE USED IN CONJUNCTION WITH COMPETITOR PRODUCTS. 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 IFU 87-6200-021-99 EN REV. B IT STATES "DO NOT USE DUAL MOBILITY LONGEVITY AND VIVACIT-E POLYETHYLENE HIP BEARINGS WITH COMPONENTS OF ANY OTHER SYSTEM OR MANUFACTURER, UNLESS AUTHORIZED BY ZIMMER BIOMET." AND IFU 87-6203-367-99 EN REV. C STATES, "ZIMMER BIOMET HAS NOT TESTED THE SAFETY OR EFFECTIVENESS OF THESE DEVICES FOR USE IN COMBINATION WITH NON-ZIMMER BIOMET PRODUCTS OR COMPONENTS. IF SURGEONS ELECT TO ASSEMBLE AND IMPLANT A CONSTRUCT THAT INCLUDES COMPONENTS NOT MANUFACTURED OR DISTRIBUTED BY ZIMMER BIOMET OR ITS AFFILIATES, THEY DO SO IN RELIANCE ON THEIR OWN CLINICAL JUDGMENT AND SHOULD SO INFORM THEIR PATIENTS". BOTH IFU'S STATE " ZIMMER BIOMET OR ITS AFFILIATES ARE NOT LIABLE FOR COMPLICATIONS AND/OR FAILURE THAT MAY ARISE FROM USE OF THE DEVICE IN CIRCUMSTANCES OUTSIDE OF ZIMMER BIOMET OR ITS AFFILIATES CONTROL INCLUDING, BUT NOT LIMITED TO, PRODUCT SELECTION AND DEVIATIONS FROM THE DEVICE¿S INDICATED USES OR SURGICAL TECHNIQUE." 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 110010247 G7 OSSEOTI 4 HOLE SHELL 58MM G 67035482. 110024465 G7 DUAL MOBILITY LINER 46MM G 66664855. 110031013 28MM I.D. 46MM O.D. SIZE G BEARING 67051331. 010001002 G7 SCREW 6.5MM X 45MM 6514808. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT TOTAL HIP ARTHROPLASTY WITH COMPETITOR PRODUCTS FOLLOWED BY A REVISION FOR AN UNKNOWN IMPLANT FAILURE. DURING THE PROCEDURE, THE COMPETITOR STEM WAS RETAINED, AND ALL OTHER PRODUCTS WERE REVISED. THE PATIENT IS NOW REPORTING SIGNIFICANT NERVE DAMAGE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457770 BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH PROSTHESIS, HIPS LPH ZIMMER MANUFACTURING B.V. N/A 66673233 00889024119826

    Patients

    Seq Age Sex Outcome Treatment
    1