BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER

    MDR report key: 7164828 · Received January 4, 2018

    Report

    Report Number
    0001825034-2018-00069
    Event Type
    Injury
    Date Received
    January 4, 2018
    Report Date
    March 6, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR'S WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034 - 2018 - 00068. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS- VERSA-DIAL/COMP TI STD TAPER P# 118001 L# 327150; COMP PRIMARY STEM 15MM STD P# 113655 L# 210550; COMP LOCKING SCREW 4.75X15MM P#180500 L# 525040; COMP LOCKING SCREW 4.75X20MM P# 180501 L# 283910; COMP RVRS SHDR GLEN BSPLT +HA P# 115330 L# 491150; COMP LOCKING SCREW 4.75X25MM P# 180502 L# 015220; COMP LOCKING SCREW 4.75X20MM P# 180501 L# 660100; COMP RVS TRAY CO 44MM P# 115370 L# 949010; ARCOM XL 44-36 STD HMRL BRNG P# XL-115363 L# 253440. PATIENT HAS STATED THAT THERE HAS BEEN SEVERAL DISLOCATIONS SINCE REVISION. DURING FOLLOW-UP VISIT THE SURGEON WAS NOT ABLE TO DUPLICATE THIS AND X-RAYS SHOWED NO EVIDENCE OF LOOSENING, DISLOCATION AND OR FRACTURE. PATIENT WAS DISCHARGED ON 1/19/17 TO A HOME EXERCISE PROGRAM. THE REPORTED EVENT COULD NOT BE CONFIRMED AS THE PRODUCT WAS NOT RETURNED, NO VISUAL AND DIMESIONAL EVALUATIONS COULD NOT BE PERFORMED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED, HOWEVER, THE COMPLAINT MAY BE REVISED UPON RECEIPT OF FURTHER INFORMATION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD MULTIPLE EPISODES OF RECURRENT DISLOCATION, INSTABILITY, "POPPING AND CATCHING", AND NUMBNESS WITH THE NEW SHOULDER THAT WAS IMPLANTED IN THE REVISION COVERED ON THIS COMPLAINT. VISIT NOTES STATE THAT THE PATIENT IMPROVED STRENGTH AND RANGE OF MOTION, AND THAT THE ISSUE WAS REPORTED TO BE RESOLVED WITH NO FURTHER COMPLAINTS AT THIS TIME, HOWEVER. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT BEGAN EXPERIENCING EPISODES OF INSTABILITY, SUBLUXATION/DISLOCATION, AND PAIN AND NUMBNESS ASSOCIATED WITH SHOULDER POPPING THAT BEGAN APPROXIMATELY ONE (1) MONTH POST-REVISION PROCEDURE. REVIEW OF FOLLOW-UP NOTES SHOW THE ISSUE HAD REPORTEDLY IMPROVED APPROXIMATELY FOUR (4) MONTHS POST-REVISION, AND SURGEON NOTED NO ISSUES WITH THE IMPLANT OR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8144 COMPREHENSIVE REVERSE SHOULDER PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED PAO ZIMMER BIOMET, INC. N/A 340660

    Patients

    Seq Age Sex Outcome Treatment
    1 Other XL-115363 ARCOM XL 44-36 STD HMRL BRNG LOT 253