BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE HUMERAL TRAY WITH LOCKING RING

    MDR report key: 6730072 · Received July 20, 2017

    Report

    Report Number
    0001825034-2017-05026
    Event Type
    Injury
    Date Received
    July 20, 2017
    Date of Event
    October 9, 2012
    Report Date
    August 22, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCT: COMPREHENSIVE SHOULDER SYSTEM PRIMARY MINI SHOULDER STEM, CATALOG#: 113630, LOT#: 199270; COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING, CATALOG#: XL-115363, LOT#: 205480 ; COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE, CATALOG#: 115310, LOT#: 258650 ; COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE BASEPLATE, CATALOG#: 115330, LOT#: 777340 ; COMPREHENSIVE REVERSE SHOULDER CENTRAL SCREW, CATALOG#: 115381, LOT#: 254110 ; FIXED LOCKING SCREW, CATALOG#: 180500, LOT#: 203120 ; FIXED LOCKING SCREW, CATALOG#: 180501, LOT#: 730560 ; VERSA-DIAL SHOULDER SYSTEM COMPREHENSIVE STANDARD ADAPTOR, CATALOG#: 118001, LOT#: 383930. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-05026, 05030, 05235. 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 · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. X-RAY REVIEW STATED "HIGH POSITION OF THE GLENOID COMPONENT BASEPLATE AND LARGE HUMERAL COMPONENT ARE BOTH FACTORS WHICH INCREASED RISK OF IMPINGEMENT, SCAPULAR NOTCHING AND MECHANICAL LOOSENING. GRADE 1 SCAPULAR NOTCHING AT THE INFERIOR PILLAR OF THE SCAPULAR NECK. LARGE HUMERAL TRAY MAY ALSO RESULT IN OVERSTUFFING OF THE GLENOHUMERAL JOINT, INCREASING CAPSULAR TENSION, LIMITING RANGE OF MOTION AND POSSIBLY CONTRIBUTING TO PECTORALIS "PULLING SENSATION". GLENOSPHERE IS NOT CIRCUMFERENTIALLY SEATED ON THE BASE PLATE, CONSISTENT WITH DISENGAGEMENT. RADIOLUCENCY AT HUMERAL TRAY METAL- BONE INTERFACE MAY BE INDICATIVE OF THE HUMERAL COMPONENT LOOSENING IF NEW OR PROGRESSIVE." DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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 · 1

    (B)(4). MEDICAL PRODUCT: COMPREHENSIVE SHOULDER SYSTEM PRIMARY MINI SHOULDER STEM, CATALOG#: 113630, LOT#: 199270. COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING, CATALOG#: XL-115363, LOT#: 205480. COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE, CATALOG#: 115310, LOT#: 258650. COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE BASEPLATE, CATALOG#: 115330, LOT#: 777340. COMPREHENSIVE REVERSE SHOULDER CENTRAL SCREW, CATALOG#: 115381, LOT#: 254110. FIXED LOCKING SCREW, CATALOG#: 180500, LOT#: 203120. FIXED LOCKING SCREW, CATALOG#: 180501, LOT#: 730560. CUSTOMER HAS INDICATED THAT DEVICE WILL NOT RETURN, AS IT IS STILL IMPLANTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-05026, 05030. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. X-RAY REVIEW STATED "HIGH POSITION OF THE GLENOID COMPONENT BASEPLATE AND LARGE HUMERAL COMPONENT ARE BOTH FACTORS WHICH INCREASED RISK OF IMPINGEMENT, SCAPULAR NOTCHING AND MECHANICAL LOOSENING. GRADE 1 SCAPULAR NOTCHING AT THE INFERIOR PILLAR OF THE SCAPULAR NECK. LARGE HUMERAL TRAY MAY ALSO RESULT IN OVERSTUFFING OF THE GLENOHUMERAL JOINT, INCREASING CAPSULAR TENSION, LIMITING RANGE OF MOTION AND POSSIBLY CONTRIBUTING TO PECTORALIS "PULLING SENSATION". GLENOSPHERE IS NOT CIRCUMFERENTIALLY SEATED ON THE BASE PLATE, CONSISTENT WITH DISENGAGEMENT. RADIOLUCENCY AT HUMERAL TRAY METAL- BONE INTERFACE MAY BE INDICATIVE OF THE HUMERAL COMPONENT LOOSENING IF NEW OR PROGRESSIVE." DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 IS REPORTED THAT THE PATIENT UNDERWENT REVERSE SHOULDER ARTHROPLASTY, AND 1 YEAR LATER EXPERIENCED A PULLING SENSATION IN THE ANTERIOR ASPECT OF HER PECTORAL MUSCLE 3 WEEKS FOLLOWING ONSET. THE ISSUE HAS SINCE RESOLVED, AND THE SURGEON DOES NOT PLAN TO REVISE. REVIEW OF PATIENT'S POST-OPERATIVE RADIOGRAPHS FOUND THE GLENOSPHERE NOT FULLY SEATED ON THE BASEPLATE, CONSISTENT WITH DISENGAGEMENT; SCAPULAR NOTCHING; AND RADIOLUCENCY AT THE HUMERAL TRAY-BONE INTERFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510427 COMPREHENSIVE REVERSE HUMERAL TRAY WITH LOCKING RING PROSTHESIS, SHOULDER PAO BIOMET ORTHOPEDICS N/A 340620

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other SEE H10 NARRATIVE