BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR GLENOID PEG TT SMALL-R #L

    MDR report key: 8734262 · Received June 26, 2019

    Report

    Report Number
    3008021110-2019-00073
    Event Type
    Injury
    Date Received
    June 26, 2019
    Date of Event
    June 20, 2019
    Report Date
    June 26, 2019
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K133349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DHR CHECK: BY CHECKING THE MANUFACTURING AND STERILIZATION CHARTS OF ALL THE COMPONENTS INVOLVED, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS MANUFACTURED WITH THESE LOT#/STER. LOT#. X-RAYS ANALYSIS: WE RECEIVED PRE-OP X-RAYS TAKEN IN (B)(6) 2018 FORWARDING THEM TO OUR MEDICAL CONSULTANT FOR A CLINICAL EVALUATION. HE COMMENTED: "I AGREE THERE IS NO OBVIOUS LYTIC REACTION IN THE DECEMBER X-RAY. THAT WOULD BE ONLY 4 MONTHS FROM IMPLANTATION AND SO IN A LOW VIRULENCE INFECTION IT WOULD NOT EXCLUDE THE POSSIBILITY. EVEN THOUGH THERE IS NO OBVIOUS LYSIS IT DOESN'T MEAN THERE IS NO INFECTION AT THAT TIME I AGREE ON THE INTRA-OPERATIVE X-RAYS THERE IS LYSIS AROUND THE PEG OF THE AXIOMA. THERE IS ALSO EVIDENCE OF IMPINGEMENT WHICH WAS ALSO PRESENT ON THE DECEMBER X-RAY." EXPLANTS ANALYSIS: EXPLANTS WERE NOT AVAILABLE TO BE RETURNED TO INCORPORATED. CONCLUSION: ACCORDING TO THE INFO RECEIVED, THE CAUSE FOR THE LOOSENING OF THE METAL BACK GLENOID IS RELATED TO INFECTION. DISLOCATION WAS ALSO REPORTED (PROBABLY CAUSED BY THE FACT THAT THE PATIENT PUSHED HIMSELF UP WITH HIS ARMS). BASED ON THE FEW INFORMATION RECEIVED, BOTH DISLOCATION AND LOOSENING CANNOT BE CLASSIFIED AS PRODUCT-RELATED EVENTS, SPECIFICALLY: -MANUFACTURING CHARTS DID NOT HIGHLIGHT PRE-EXISTING ANOMALIES ON THE COMPONENTS MANUFACTURED WITH THE LOTS INVOLVED; STERILIZATIONS CHARTS DID NOT HIGHLIGHT PRE-EXISTING ANOMALIES ON THE COMPONENTS MANUFACTURED WITH THESE STER. LOT#S, MEANING THAT THE COMPONENTS HAD BEEN REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET; EXPLANTS WERE NOT RETURNED, THUS, NO INSPECTION CAN BE PERFORMED ON THEM; -THE INFORMATION ON GERM RESPONSIBLE AND SUBSEQUENT STAGE OF REVISION SURGERY NOT AVAILABLE; OUR MEDICAL EXPERT'S ANALYSIS CONFIRMED THE POSSIBILITY THAT INFECTION WAS PRESENT (EVEN IF NOT CLEARLY VISIBLE ON THE X-RAYS PROVIDED). PMS DATA: ACCORDING TO OUR PMS DATA, WE CAN ESTIMATE THE SPECIFIC REVISION RATES AS FOLLOWS: INFECTION RATE FOR SMR REVERSE OF (B)(4). REVISION RATE OF SMR REVERSE DUE TO DISLOCATION OF (B)(4). NO CORRECTIVE ACTION FOR THIS SPECIFIC CASE. INCORPORATED WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT FUTURE SIMILAR EVENTS.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY DUE TO LOOSENING OF THE GLENOID COMPONENT CAUSED BY INFECTION. REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2019, PREVIOUS SURGERY ON THE (B)(6) 2018. MOREOVER, ACCORDING TO THE INFO REPORTED, THE PATIENT PUSHED HIMSELF UP AND CONSEQUENTLY DISLOCATED. THE PRE OP X-RAY DID NOT HIGHLIGHT SIGNS OF INFECTIONS, HOWEVER ON THE INTRA-OP IMAGES, GLENOID METAL BACK APPEARED LOOSE AND THERE WAS PUS ON THE GLENOID CONNECTOR SCREW. THE SURGEON WAS CONVINCED THERE WAS AN INFECTION IN THE GLENOID. ALL THE COMPONENTS THAT WERE EXPLANTED ARE LISTED BELOW: 1304.15.190, FINNED STEM, LOT #1715142, STER.1800060; 1352.15.001, HUMERAL EXTENSION, LOT #170769, STER.1700273; 1352.20.010, HUMERAL BODY, LOT #1809868, STER.1800239; 1362.09.010, REVERSE HP LINER, LOT #1709121, STER.1700351; 1374.15.305, SMR CONNECTOR, LOT #1810779, STER.1800239 ; 1374.50.440, REVERSE GLENOSPHERE, LOT #1810699, STER.180022; 1375.14.653, GLENOID PEG TT, LOT #1506737, STER.1500222; 1375.15.605, GLENOID BASEPLATE, LOT #1708320, STER.1700296; 8431.15.028, BONE SCREW, LOT #1702433, STER.1700359; 8431.15.040, BONE SCREW, LOT #1702124, STER.1800049. ANTIBIOTIC BONE GRAFT CHIPS WERE INSERTED IN THE GLENOID AND A CEMENT SPACER IN THE HUMERAL PART. SAMPLES WERE SENT FOR SWAB TESTING. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED ON THE TESTS RESULTS NOR ON THE SECOND STAGE OF THE REVISION SURGERY. EVENT HAPPENED IN NEW ZEALAND.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE MANUFACTURING AND STERILIZATION CHARTS OF THE COMPONENTS INVOLVED, NO ANOMALY WAS FOUND. THEREFORE, WE CAN ENSURE THAT ALL THE COMPONENTS HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. WE WILL SUBMIT A FINAL REPORT ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO LOOSENING OF THE GLENOID COMPONENT OCCURRED ON (B)(6) 2019. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2018. ACCORDING TO THE INFO REPORTED, THE PATIENT WHO IS A KNEE AMPUTEE, PUSHED HIMSELF UP AND CONSEQUENTLY DISLOCATED. HOWEVER, ON THE INTRAOP IMAGING TAKEN IT APPEARED THAT THE GLENOID MAY BE LOOSE. IT WAS FOUND THERE WAS PUS ON THE GLENOID CONNECTOR SCREW AND SURGEON WAS CONVINCED THAT THERE WAS AN INFECTION IN THE GLENOID. ALL THE IMPLANTED COMPONENTS WERE EXPLANTED AND ARE FOLLOWING LISTED: 1304.15.190, SMR CEMENTLESS FINNED STEM, LOT #1715142, STER.1800060. 1352.15.001, SMR HUMERAL EXTENSION + 9 MM, LOT #1707698, STER.1700273. 1374.15.305, SMR CONNECTOR SMALL R, LOT #1810779, STER.1800239. 1375.14.653, SMR GLENOID PEG TT SMALL-R #L, LOT #1506737, STER.1500222. 1375.15.605, SMR GLENOID BASEPLATE SMALL-R, LOT #1708320, STER.1700296. SMR REVERSE HUMERAL BODY, NOT MARKED IN USA. SMR REVERSE HP LINER SHORT, NOT MARKED IN USA. SMR REVERSE HP GLENOSPH. 44 MM, NOT MARKED IN USA. CORTIC. BONE SCREW D.4,5 L.28MM, NOT MARKED IN USA. CORTIC.BONE SCREW D.4,5 L.40MM, NOT MARKED IN USA. CEMENT SPACER WAS IMPLANTED AND SAMPLES WERE SENT FOR SWAB TESTING. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529511 SMR GLENOID PEG TT SMALL-R #L SMR GLENOID PEG TT SMALL-R #L (KWS-KWT) KWS LIMACORPORATE S.P.A. 1375.14.653 1506737

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention