BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER F. MET.BACK GLEN.SMALL-R

    MDR report key: 8486938 · Received April 5, 2019

    Report

    Report Number
    3008021110-2019-00045
    Event Type
    Injury
    Date Received
    April 5, 2019
    Date of Event
    March 20, 2019
    Report Date
    September 30, 2019
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    KWS
    PMA / PMN Number
    K113254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DHR CHECK: BY CHECKING THE DHRS OF THE INVOLVED LOT# NO PRE - EXISTING ANOMALY WAS FOUND ON A TOTAL OF (B)(4) LINERS MANUFACTURED WITH LOT #1213633: THE LINERS HAD BEEN MANUFACTURED UP TO SPECS, NO DEVIATION DETECTED. ADDITIONALLY, ACCORDING TO OUR RECORDS, AT LEAST 33 LINERS WITH THE SAME LOT# HAVE ALREADY BEEN IMPLANTED WITHOUT RECEIVING ADDITIONAL COMPLAINTS. EXPLANTS ANALYSIS: EXPLANTED LINER WAS NOT AVAILABLE TO BE RETURNED TO LIMA CORPORATE FOR ANALYSIS. WE RECEIVED SOME PICTURES OF THE EXPLANTS. BY LOOKING AT THE IMAGE OF THE LINER WE COULD CONFIRM THAT THIS COMPONENT WAS STRONGLY WORN. HOWEVER, AS THE COMPONENT HAS NOT BEEN RETURNED, NO DEEPER EVALUATION IS POSSIBLE. X-RAYS ANALYSIS: WE RECEIVED SOME X-RAYS REFERRING TO THE PRE-OP CONVERSION (EXACT DATE NOT KNOWN) EVALUATED BY OUR MEDICAL CONSULTANT. FOLLOWING HIS OPINION: "THE PROSTHESIS HAS SURVIVED FOR 6 YEARS SO I AM GOING TO PRESUME THERE WAS AN AT LEAST SATISFACTORY OUTCOME AND WITH TIME MY "GUESS" IS THAT SUBSCAPULARUS HAS FAILED RESULTING IN ANTERIOR SUBLUXATION AND FAILURE. CAUSATIVE FACTORS INCLUDE PATIENT FACTORS WITH DEGENERATION OF THE TENDON. WITH OR WITHOUT THAT THERE ARE SURGICAL FACTORS INCLUDING SLIGHT VARUS MALALIGNMENT OF THE STEM RESULTING IN LATERAL OFFSET, THE (HUMERAL) BODY IS TOO LOW AND THE (FEMORAL) HEAD SLIGHTLY TOO LARGE. THE COMBINATION RESULTS IN A SIGNIFICANTLY SUB OPTIMAL POSITIONING AND MODERATE OVERSTUFFING THAT WILL SUBJECT THE CUFF TO ABNORMAL LOADING. SO WITH OR WITHOUT THE PATIENT FACTOR (PRE EXISTING DEGENERATION OF THE CUFF) THERE ARE SIGNIFICANT SURGICAL FACTORS." CONCLUSION: ACCORDING TO OUR ANALYSIS, MOST PROBABLE CAUSE FOR THIS CONVERSION WAS RELATED TO A COMBINATION OF PATIENT'S CUFF FAILURE AND SUBOPTIMAL POSITIONING OF THE IMPLANT DURING THE PREVIOUS SURGERY. THE LINER WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER SO NO DEEPER INVESTIGATION IS POSSIBLE. HOWEVER, THE CHECK OF THE MANUFACTURING CHARTS CONFIRMED THE ABSENCE OF PRE-EXISTING ANOMALY ON THE COMPONENTS MANUFACTURED WITH THE SAME LOT# (#1213633). EVENT NOT PRODUCT-RELATED. PMS DATA: ACCORDING TO OUR PMS DATA, REVISION RATE FOR SMR ANATOMIC PROSTHESIS, RELATED TO THE WEAR OF THE L1 LINERS (1377.50.005/020/010/030) IS (B)(4). NO SPECIFIC CORRECTIVE ACTION FOR THIS CASE. LIMA CORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FUTURE SIMILAR ISSUE.

    Description of Event or Problem · 0

    CONVERSION FORM SMR ANATOMIC TO SMR REVERSE PROSTHESIS OCCURRED ON (B)(6) 2019 DUE TO SHOULDER DISLOCATION CAUSED BY CUFF FAILURE AND DEGENERATIVE TEAR. DURING THE CONVERSION SURGERY, L1 LINER (CODE #1377.50.005, LOT #1213633) PREVIOUSLY IMPLANTED WAS FOUND STRONGLY WORN. ACCORDING TO THE SURGEON THERE WAS NO TRAUMATIC EVENT REPORTED BY THE PATIENT (MOST PROBABLY THE LINER HAD BEEN WORN OVER YEARS). PRIMARY SURGERY OCCURRED ON (B)(6) 2013. DURING THE CONVERSION PERFORMED ON (B)(6) 2019, SURGEON REMOVED BOTH THE FEMORAL HEAD (CODE #1322.09.460, LOT # 1305003) AND THE ADAPTOR TAPER (CODE # 1330.15.270, LOT #1214203) BY CONVERTING TO SMR REVERSE. EVENT HAPPENED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHRS OF THE INVOLVED LOT#S NO PRE - EXISTING ANOMALIES WERE FOUND. WE WILL SUBMIT A FINAL REPORT ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    SHOULDER REVISION SURGERY OCCURRED ON (B)(6) 2019 DUE TO DISLOCATION CAUSED BY CUFF FAILURE AND DEGENERATIVE TEAR. PRIMARY SURGERY OCCURRED ON (B)(6) 2013. DURING REVISION SURGERY, IT WAS FOUND THAT THE L1 LINER HAD BEEN STRONGLY WORN. THE ANATOMIC PROSTHESIS WAS CONVERTED TO REVERSE AND ALL THE FOLLOWING COMPONENTS WERE EXPLANTED LINER F. MET.BACK GLEN. SMALL-R, CODE #1377.50.005, LOT #1213633. SMR HUMERAL HEAD Ø46 MM CODE #1322.09.460, LOT # 1305003. SMR CEMENTLESS FINNED STEM Ø15 CODE # 1304.15.150, LOT # 1303528. NEUTRAL ADAPTOR TAPER STANDARD CODE # 1330.15.270, LOT #1214203. SMR FINNED HUMERAL BODY CODE # 1350.15.110, LOT #1304139. SMR UNCEMENT. GLENOID #SMALL-R CODE #1375.20.005, LOT #1203319. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280450 LINER F. MET.BACK GLEN.SMALL-R LINER F. MET.BACK GLEN.SMALL-R KWS LIMACORPORATE SPA 1377.50.005 1213633

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention