BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CEMENTL. REV. STEM Ø13 MM

    MDR report key: 8059330 · Received November 12, 2018

    Report

    Report Number
    3008021110-2018-00105
    Event Type
    Injury
    Date Received
    November 12, 2018
    Date of Event
    November 3, 2018
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K113523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DHRS CHECK: WE CHECKED THE DHRS OF THE INVOLVED COMPONENTS AND NO PRE-EXISTING ANOMALY WAS DETECTED ON A TOTAL OF 37 LINERS MANUFACTURED WITH LOT#1515020. NO PRE-EXISTING ANOMALY EVEN ON A TOTAL OF 20 STEMS MANUFACTURED WITH LOT# 1113235. MOREOVER, ACCORDING TO OUR RECORDS: -17 OUT OF 20 STEMS WITH LOT# 1113235 HAVE ALREADY BEEN IMPLANTED WITHOUT RECEIVING ADDITIONAL COMPLAINTS ON THE SAME LOT#; - 37 OUT OF 37 LINERS WITH LOT# 1515020 HAVE ALREADY BEEN IMPLANTED WITHOUT RECEIVING ADDITIONAL COMPLAINTS ON THE SAME LOT#. EXPLANTS ANALYSIS: EXPLANTS WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE. ACCORDING TO THE INFO REPORTED, EXPLANTS WERE DISPOSED OF AS PER HOSPITAL POLICY. XRAYS ANALYSIS: WE RECEIVED THE FOLLOWING X-RAYS, EXAMINED BY OUR MEDICAL CONSULTANT: -PRE-OPERATIVE X-RAYS REFERRING TO PREVIOUS REVISION SURGERY PERFORMED ON (B)(6) 2018 (EXACT DATA UNKNOWN) -PRE-OPERATIVE X-RAYS REFERRING TO THE REVISION SURGERY PERFORMED ON (B)(6) 2018 (TAKEN ON (B)(6) 2018) FOLLOWING, THE COMMENTS RECEIVED FROM OUR MEDICAL CONSULTANT: 1. CONCERNING PREVIOUS REVISION SURGERY (COMPLAINT #316/18, PATIENT-RELATED, NOT REPORTED TO FDA): "THERE IS EVIDENCE OF SCREW HOLES IN THE HUMERAL SHAFT.THIS COMBINED WITH THE APPEARANCE OF THE ACROMIUM AND THE RESIDUAL GLENOID INDICATES THE LIKELY ORIGINAL PATHOLOGY WAS A FRACTURE THAT WAS PLATED. THE ORIGINAL PLATE PROSTHESIS HAS BEEN REMOVED AND REVISED TO A REVERSE TSJR WHICH HAS DISLOCATED SOON AFTER IMPLANTATION AND HENCE FURTHER REVISION 2 WEEKS LATER AS YOU DESCRIBE. THERE ARE NO OBVIOUS RESIDUAL TUBEROSITIES SO IMMEDIATELY THIS IMPLANT WILL HAVE AT LEAST SOME INSTABILITY. THE POSITION OF THE GLENOID BASE PLATE IS IDEAL WITH THE BOTTOM OF THE GLENOID BASEPLATE FLUSH WITH THE INFERIOR BORDER OF THE NATIVE GLENOID. WE CAN REASONABLY ASSUME THERE HAS BEEN NO BONE STOCK LOSS FROM THE GLENOID AND THERE DOES NOT APPEAR TO BE ANY INDICATION THAT INCREASING LATERAL OFFSET WOULD BE BENEFICIAL. IN SUMMARY THE INSTABILITY WILL HAVE BEEN PARTICULARLY RELATED TO THE ABSENCE OF THE STABILISING EFFECTS OF ATTACHED TUBEROSITIES". 2. CONCERNING REVISION SURGERY PERFORMED ON 3RD NOVEMBER 2018: "OTHER THAN THE JOINT BEING DISLOCATED THERE IS NO EVIDENCE OF RETAINED TUBEROSITIES SO THAT IS ONE FACTOR LEADING TO INSTABILITY. THE IMAGES PROVIDED DON'T ALLOW AN ACCURATE ASSESSMENT OF THE BASEPLATE POSITION BUT I AM UNABLE TO SEE ANY OTHER RADIOLOGICAL FACTORS LEADING TO INSTABILITY". CONCLUSIONS: WE CANNOT GO BACK WITH CERTAINTY TO THE ROOT CAUSE OF THE SECOND PROSTHESIS DISLOCATION REPORTED BUT, BY THE ANALYSIS PERFORMED, WE CANNOT CLASSIFY THIS CASE AS PRODUCT-RELATED. NO PRE-EXISTING ANOMALIES HAVE BEEN FOUND ON THE INVOLVED COMPONENTS BY CHECKING THEIR DHRS. MOREOVER, ACCORDING TO OUR MEDICAL EXPERT'S OPINION, THE MOST PROBABLE CAUSE FOR DISLOCATION AND CONSEQUENT REVISION SURGERY WAS RELATED TO PATIENT'S ANATOMY ("THERE IS NO EVIDENCE OF RETAINED TUBEROSITIES SO THAT IS ONE FACTOR LEADING TO INSTABILITY"). FURTHERMORE, WE CAN SPECULATE THAT AN ORIGINAL SUBOPTIMAL CHOICE OF COMPONENTS COULD HAVE CONTRIBUTED TO THE INSTABILITY OF THE IMPLANT (AS CONFIRMED BY SURGEON'S DECISION TO REPLACE THE STEM AND THE LINER WITH DIFFERENT PRODUCT SIZES/MODELS). NOTE: THE SUSPECTED PRODUCT CODE IS NOT MARKETED IN USA, THIS EVENT WAS REPORTED TO FDA BECAUSE THE INVOLVED STEM (CODE 1308.15.134, LOT# 1113235) IS MARKETED IN USA. PMS DATA: ACCORDING TO OUR PMS DATA, REVISION RATE OF SMR REVERSE SYSTEM INVOLVING COCRMO REVERSE HP LINERS (PRODUCT CODES 1365.09.XXX, 1362.09.XXX) - AND WITH REFERENCE TO REVISION SURGERIES DUE TO DISLOCATION - IS 0.08%. A TOTAL OF MORE THAN 40980 REVERSE HP LINERS SOLD FROM 2007. NONE OF THE CASES WE COULD INVESTIGATE WAS CLASSIFIED AS PRODUCT RELATED. NO SPECIFIC CORRECTIVE ACTION FOR THIS CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE.

    Description of Event or Problem · 0

    SMR REVERSE REVISION SURGERY DUE TO IMPLANT DISLOCATION, PERFORMED ON (B)(6), 2018. PREVIOUS SURGERY PERFORMED ON (B)(6), 2018. ACCORDING TO THE INFO RECEIVED, THE SURGERY PERFORMED ON OCTOBER 1ST WAS ALSO A REVISION SURGERY DUE TO DISLOCATION: REPLACEMENT OF THE SHORT LINER PREVIOUSLY IMPLANTED WITH A LONG LINER (CODE 1365.09.020, LOT# 1515020) WAS PERFORMED AT THAT TIME. PREVIOUS SURGERY WAS REGISTERED AS OUR COMPLAINT #316/18 (REVISION SURGERY DUE TO DISLOCATION), BUT IT HAS NOT BEEN REPORTED TO TGA AS THE ROOT CAUSE FOR DISLOCATION WAS RELATED ONLY TO PATIENT'S ANATOMICAL CONDITION. PRIMARY SURGERY TOOK PLACE ON (B)(6) 2018. DURING REVISION SURGERY PERFORMED ON NOVEMBER 3RD, THE SURGEON REPLACED THE STEM (CODE 1308.15.134, LOT# 1113235) WITH A LARGER CEMENTED STEM (CODE 1309.15.154) AND THE LONG LINER (CODE 1365.09.020, LOT# 1515020, IMPLANTED ON OCTOBER 1ST) WITH A LONG LATERALIZING LINER (CODE 1365.09.120). AN EXTENSION FOR HUMERAL BODY HAS ALSO BEEN IMPLANTED (1352.15.001). ACCORDING TO THE INFO PROVIDED, THE SURGEON WAS ABLE TO PULL OUT THE IMPLANT WITH HIS FINGERS AS THE STEM WASN'T STABLE. THUS, IT HAS BEEN DECIDED TO UPSIZE THE STEM AND INSERT A LATERALIZED LINER. SURGEON WAS HAPPY WITH THE FINAL STABILITY OF THE IMPLANT. EVENT HAPPENED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    SMR REVERSE REVISION SURGERY DUE TO IMPLANT DISLOCATION, PERFORMED ON (B)(6) 2018. PREVIOUS SURGERY PERFORMED ON (B)(6) 2018. ACCORDING TO THE INFO RECEIVED, THE SURGERY PERFORMED ON (B)(6) WAS ALSO A REVISION SURGERY DUE TO DISLOCATION: REPLACEMENT OF THE SHORT LINER PREVIOUSLY IMPLANTED, WITH A LONG LINER (CODE 1365.09.020, LOT# 1515020). PRIMARY SURGERY TOOK PLACE ON (B)(6) 2018. DURING REVISION PERFORMED ON (B)(6) SURGEON REPLACED THE STEM (CODE 1308.15.134, LOT# 1113235) WITH A LARGER CEMENTED STEM (CODE 1309.15.154) AND THE LONG LINER (CODE 1365.09.020, LOT# 1515020) WITH A LONG LATERALISING LINER (CODE 1365.09.120). SURGEON WAS HAPPY WITH THE FINAL OUTCOME. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902413 SMR CEMENTL. REV. STEM Ø13 MM UNCEMENTED REVISION STEMS (TI6AL4V) DIA.13MM, H.150MM KWS LIMACORPORATE S.P.A. 1308.15.134 1113235

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention