BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHELL POROUS WITH CLUSTER HOLES

    MDR report key: 9239312 · Received October 25, 2019

    Report

    Report Number
    0001822565-2019-04556
    Event Type
    Injury
    Date Received
    October 25, 2019
    Date of Event
    November 29, 2017
    Report Date
    November 13, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K021891
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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/CORRECTED UPDATED: B4, B5, G4, G7, H2, H3, H6, H10 CORRECTED: G3 THE EVENT WAS CONFIRMED WITH MEDICAL RECORDS RECEIVED. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: -PRIMARY OP NOTES WERE REVIEWED AND NO COMPLICATIONS WERE NOTED. -REVISION OP NOTES WERE REVIEWED AND IDENTIFIED: RECURRENT DISLOCATION, RIGHT TOTAL HIP. PATIENT HAD FEELING OF POPPING AND INSTABILITY. ALTHOUGH SHE NEVER PRESENTED TO THE ED WITH A DISLOCATION REQUIRING REDUCTION, SHE WAS ABLE TO VOLUNTARILY DISLOCATE HER HIP IN THE OFFICE. -FILMS SHOWED ADEQUATE POSITION OF THE IMPLANT, EXCEPT FOR SOME LESS THAN IDEAL ANTEVERSION OF THE CUP. JOINT FLUID CLEAR BUT CAPSULAR TISSUE WAS STAINED BLACK WITH METAL DEBRIS. POSTERIOR SUPERIOR LIP OF THE POLYETHYLENE LINER WAS CRACKED AND BROKEN. THE STEM APPEARED TO BE WELL INGROWN. IT WAS WELL POSITIONED IN 15 DEGREES OF ANTEVERSION. THERE WAS ABUNDANT PSEUDOCAPSULE, WHICH APPEARED INFLAMED BUT NOT INFECTED ALTHOUGH IT WAS STAINED WITH DEBRIS. THE LOCKING MECHANISM WAS JAMMED. THIS REQUIRED FRAGMENTING THE LINER WITH OSTEOTOMES AND REMOVING IN PIECES. THE HEAD OF THE ACETABULAR SCREW STRIPPED OUT DURING REMOVAL. THE SCREW WAS EVENTUALLY REMOVED WITH PENCIL TIP BURR AND PLIERS. THE TRABECULAR METAL SHELL HAD CLOSE TO 100% BONY INGROWTH. THE ACETABULUM WAS THEN PREPPED FOR COMPETITORS PRODUCT. THE FINAL CERAMIC HEAD WAS ASSEMBLED AND IMPACTED ON A CLEAN DRY MORSE TAPER. THE HIP WAS REDUCED. THERE WAS NO CHANGE IN LIMB LENGTH OR STABILITY AS COMPARED WITH THE TRIAL REDUCTION. THE WOUND WAS LAVAGED WITH DILUTE BETADINE SOLUTION THEN NORMAL SALINE. THE WOUND WAS CLOSED IN LAYERS. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE COULD NOT 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 Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. UPDATED: D9, G1-2, G3, G6, H2, H3, H6. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE SHELL IS RETURNED WITH BIO DEBRIS COVERING THE TM PAD. A BORE APPROXIMATELY .500¿ GOES THROUGH THE SHELL. DAMAGE IS SEEN IN THE INNER SPHERICAL SURFACE AND RIM FEATURE. THE FEMORAL HEAD EXHIBITS DAMAGE ON THE OUTER SPHERICAL SURFACE. THE TAPER SHOWS A CIRCUMFERENTIAL GROOVE PATTERN, BUT BLACK DEBRIS WAS NOT IDENTIFIED ON THE DEVICE. THE POLY LINER WAS RETURNED WITH A PORTION OF THE RIM FEATURE REMOVED. DAMAGE IS SEEN IN THE INNER AND OUTER SURFACES. A BONE SCREW WAS RETURNED WITHOUT THE HEX HEAD FEATURE. DAMAGE IS SEEN THROUGHOUT THE LENGTH OF THE THREAD FORM. THE HEAD AND SHELL SIZES WERE CONFIRMED CONFORMING TO PRINT SPECIFICATION. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THE STEM, SHELL, AND SCREW AND THE REPORTED PART AND LOT COMBINATION. ROOT CAUSE UNCHANGED. IT IS UNKNOWN IF THE SHELL WAS PLACED WITH THE NOTED ANTEVERSION FROM THE REVISION OR MIGRATED FROM THE INITIAL SURGERY. IT WAS NOTED THE SHELL HAD ALMOST 100% BONY INGROWTH. THIS COMPLAINT WAS CONFIRMED BASED ON THE PROVIDED MEDICAL RECORDS CONFIRMING 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.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL RIGHT THA. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 9 YEARS AFTER THE INITIAL DUE TO INSTABILITY, DISLOCATION, IMPLANT FRACTURE, PSEUDOCAPSULE/PSEUDOTUMOR, ADVERSE LOCAL TISSUE REACTION, MIGRATION, AND TISSUE DAMAGE. MEDICAL RECORDS INDICATE THAT DURING THE REVISION PROCEDURE, IT WAS NOTED THAT THERE WAS CLEAR JOINT FLUID BUT THE CAPSULAR TISSUE WAS STAINED BLACK WITH METAL DEBRIS. FURTHER, THE POSTERIOR SUPERIOR LIP OF THE POLYETHYLENE LINER WAS FRACTURED. ADDITIONALLY, THE HEAD OF THE ACETABULAR SCREW STRIPPED OUT DURING REMOVAL. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER, PN 00801803603, LN 61192708 LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 50/52/54 MM O.D. SHELLS, PN 00630505036, LN 61281054. FEMORAL STEM FIBER METAL MIDCOAT COLLARLESS 12/14 NECK TAPER EXTENDED NECK OFFSET CEMENTLESS SIZE 12 STANDARD BODY, PN 00784501220, LN 60283141 BONE SCR 6.5X25 SELF-TAP, PN 00625006525, LN 61233964. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS 0002648920-2019-00764, 0002648920-2019-00765, 0001822565-2019-04557. 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 · 1

    IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL RIGHT THA. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 9 YEARS AFTER THE INITIAL DUE TO INSTABILITY, DISLOCATION, IMPLANT FRACTURE, PSEUDOCAPSULE/PSEUDOTUMOR, ADVERSE LOCAL TISSUE REACTION, MIGRATION, AND TISSUE DAMAGE. MEDICAL RECORDS INDICATE THAT DURING THE REVISION PROCEDURE, IT WAS NOTED THAT THERE WAS CLEAR JOINT FLUID BUT THE CAPSULAR TISSUE WAS STAINED BLACK WITH METAL DEBRIS. FURTHER, THE POSTERIOR SUPERIOR LIP OF THE POLYETHYLENE LINER WAS FRACTURED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031928 SHELL POROUS WITH CLUSTER HOLES PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 61305013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H10 NARRATIVE.