BEUDAMED
    FDA Adverse Event Death Summary report: N

    R3 3 HOLE ACET SHELL 52MM

    MDR report key: 14068225 · Received April 9, 2022

    Report

    Report Number
    1020279-2022-01709
    Event Type
    Death
    Date Received
    April 9, 2022
    Date of Event
    March 14, 2020
    Report Date
    June 10, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBL
    UDI-DI
    03596010598240
    PMA / PMN Number
    K070756
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICE WAS NOT RETURNED FOR EVALUATION BUT THE PICTURES WERE REVIEWED, AND THE FAILURE MODE WAS CONFIRMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, THIS CLINICAL STUDY REPORTED THE PATIENT PASSED AWAY ON (B)(6) 2020. HOWEVER, THE CAUSE OF DEATH IS UNKNOWN. THE ATTACHED CRFS WERE REVIEWED BUT PROVIDED NO INSIGHT INTO THE REPORTED DEATH. IN ADDITION, 2 X-RAY LINKS WERE PROVIDED IN AN UNREADABLE FORMAT. THEREFORE, NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. SHOULD ANY ADDITIONAL RELEVANT SUPPORTING MEDICAL INFORMATION BE PROVIDED, THIS COMPLIANT WOULD BE RE-ASSESSED. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A REVIEW OF COMPLAINT HISTORY FOR THE PART NUMBER OVER THE PAST 12 MONTHS AND FOR THE BATCH NUMBER BASED ON HISTORICAL DATA OF THE DEVICE DID NOT REVEAL SIMILAR EVENTS FOR THE LISTED DEVICE. A REVIEW OF THE INSTRUCTIONS FOR USE DOCUMENTS FOR TOTAL HIP SYSTEMS PROVIDES COMPLETE GUIDELINES OF INDICATIONS, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS AND POSSIBLE ADVERSE EFFECTS THAT MAY OCCUR PREOPERATIVE, DURING SURGERY OR POST OPERATIVE. A HISTORICAL REVIEW CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THIS PRODUCT AND EVENT. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE PATIENT DIED 10 YEARS AFTER THE IMPLANTATION OF THE COMPLAINED DEVICE AND THE CAUSE OF DEATH IS UNKNOWN. THERE IS NO INDICATION THAT THE IMPLANT CONTRIBUTED IN ANY MANNER TO THE DEATH OF THE PATIENT. WITHOUT DETAILS OF THE ALLEGED FAULT, MALFUNCTION OR DEATH, NO PROBABLE CAUSE CAN BE DELINEATED THAT RELATES THE EVENT WITH THE DEVICE. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE CORROBORATED. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 0

    H3, H6, THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, IT SHOULD BE NOTED THE PATIENT HAD COMORBIDITIES THAT WERE REPORTED AS ONGOING THE YEAR PRIOR TO THEIR DEATH THAT COULD HAVE CONTRIBUTED TO THEIR DEATH. BASED ON THE INFORMATION PROVIDED THE CAUSE OF DEATH CANNOT BE CONFIRMED. WE CANNOT CONCLUDE THE S+N PRODUCTS WERE RELATED TO THE CAUSE OF DEATH. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A REVIEW OF COMPLAINT HISTORY FOR THE PART NUMBER OVER THE PAST 12 MONTHS AND FOR THE BATCH NUMBER BASED ON HISTORICAL DATA OF THE DEVICE DID NOT REVEAL SIMILAR EVENTS FOR THE LISTED DEVICE. A REVIEW OF THE INSTRUCTIONS FOR USE DOCUMENTS FOR TOTAL HIP SYSTEMS PROVIDES COMPLETE GUIDELINES OF INDICATIONS, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS AND POSSIBLE ADVERSE EFFECTS THAT MAY OCCUR PREOPERATIVE, DURING SURGERY OR POST OPERATIVE. A HISTORICAL REVIEW CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THIS PRODUCT AND EVENT. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE PATIENT DIED 10 YEARS AFTER THE IMPLANTATION OF THE COMPLAINED DEVICE AND THE CAUSE OF DEATH IS UNKNOWN. THERE IS NO INDICATION THAT THE IMPLANT CONTRIBUTED IN ANY MANNER TO THE DEATH OF THE PATIENT. WITHOUT DETAILS OF THE ALLEGED FAULT, MALFUNCTION OR DEATH, NO PROBABLE CAUSE CAN BE DELINEATED THAT RELATES THE EVENT WITH THE DEVICE. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE CORROBORATED. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A BILATERAL THR SURGERY PERFORMED (ONLY ONE IS FROM SMITH AND NEPHEW) ON (B)(6) 2010, THE CLINICAL SUBJECT PASSED AWAY ON (B)(6) 2020. THE CAUSE OF DEATH IS UNKNOWN. FURTHER INFORMATION IS NOT AVAILABLE AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1187096 R3 3 HOLE ACET SHELL 52MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS MBL SMITH & NEPHEW, INC. 71335552 10EM14114 03596010598240

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Death