BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    DELTA CER FEM HD 28/-3MM T1

    MDR report key: 11011740 · Received December 15, 2020

    Report

    Report Number
    3002806535-2020-00530
    Event Type
    Injury
    Date Received
    December 15, 2020
    Date of Event
    November 17, 2020
    Report Date
    February 26, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    OQG
    PMA / PMN Number
    K131684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRODUCTS HAVE BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION AND FORWARDED TO THE COMPLAINTS PROCESSING UNIT FOR INVESTIGATION. X-RAYS: SEVEN ANTEROPOSTERIOR X-RAYS (IN FIVE IMAGES) WERE PROVIDED FOR ANALYSIS WITH (B)(4): TWO PRE-PRIMARY SURGERY X-RAYS OF THE LEFT HIP AND ONE FULLPELVIS PRE-PRIMARY SURGERY X-RAY, ALL DATED (B)(6) 2020, WHERE THE FRACTURED FEMORAL NECK IS VISIBLE; ONE FULL-PELVIS X-RAY TAKEN ON AN UNKNOWN DATE, BUT LABELLED POSTOPERATIVE X-RAY OF THE INITIAL SURGERY-2; ONE FULL-PELVIS X-RAY, DATED (B)(6) 2020 (THE DAY BEFORE THE FIRST REVISION SURGERY) AND LABELLED POSTOPERATIVE X-RAY OF THE INITIAL SURGERY-1; TWO FULL-PELVIS X-RAYS LABELLED PREOPERATIVE X-RAY THE SECOND REVISION SURGERY, ONE TAKEN ON AN UNKNOWN DATE, AND THE OTHER DATED (B)(6) 2020. (B)(4) AND THE LINKED COMPLAINT (B)(4) ADDRESS THE SECOND REVISION SURGERY DUE TO DISLOCATION (CARRIED OUT ON (B)(6) 2020), AND THEREFORE ONLY THE TWO X-RAYS LABELLED PREOPERATIVE X-RAY THE SECOND REVISION SURGERY WILL BE CONSIDERED RELEVANT FOR THIS ASSESSMENT. THE FIRST REVISION SURGERY (CARRIED OUT ON (B)(6) 2020) IS ADDRESSED IN THE LINKED COMPLAINTS (B)(4) AND (B)(4). THE X-RAY LABELLED POSTOPERATIVE X-RAY OF THE INITIAL SURGERY-1 SHOWS THE BIOLOX DELTA FEMORAL HEAD AND ACTIVE ARTICULATION E1 BEARING DISLOCATED FROM THE M2A-MAGNUM ACETABULAR SHELL. ALTHOUGH THE IMAGE OF THE RADIOGRAPH WAS TAKEN AT A SLIGHT ANGLE, IT ALLOWS FOR THE APPROXIMATE MEASUREMENT OF THE INCLINATION ANGLE OF THE ACETABULAR SHELL, WHICH WAS FOUND TO BE 60.6°. THIS IS FURTHER SUPPORTED BY THE TWO XRAYS LABELLED PREOPERATIVE X-RAY THE SECOND REVISION SURGERY, WHICH HAVE INCLINATION ANGLE MEASUREMENTS MARKED ON THEM SHOWING THE VALUES OF 55.82° AND 55.75°. THE ACTIVE ARTICULATION DUAL MOBILITY HIP SYSTEM SURGICAL TECHNIQUE RECOMMENDS THAT THE ACETABULAR SHELL BE POSITIONED AT 40 OR 45 DEGREES INCLINATION. A REPORT BY MEDICAL METRICS INC. (AVAILABLE WITH (B)(4)) CONFIRMS AN ACETABULAR INCLINATION ANGLE OF 57°, AND STATES THAT A POSSIBLE OVERSIZED ACETABULAR CUP WAS IMPLANTED. THE PATIENT IS FEMALE, 65 YEARS OLD AND SUFFERS FROM PARKINSON DISEASE, AS STATED IN THE COMPLAINT DESCRIPTION. THE COMPLAINT DESCRIPTION IN THE LINKED COMPLAINT (B)(4) SUGGESTS THAT TWO CLOSED REDUCTIONS WERE ALSO CARRIED OUT AND THAT ANOTHER DISLOCATION OCCURRED WHEN THE PATIENT WAS PUTTING ON SOCKS, HOWEVER IT IS NOT CLEAR WHEN THESE EVENTS OCCURRED AND IF THEY ARE RELATED TO THE SECOND REVISION. EMAIL COMMUNICATION REPORTED THAT THE DOCTOR DOES NOT ATTRIBUTE THE PATIENTS FALLS AND WEARING OF SOCKS TO THE DISLOCATIONS. DURING THE SECOND REVISION SURGERY, THE ACETABULAR COMPONENT AND FEMORAL STEM WERE NOT REVISED. ONLY THE FEMORAL HEAD AND E1 BEARING WERE REVISED. THESE WERE REPLACED WITH AN IDENTICAL ACTIVE ARTICULATION E1 28 MM BEARING, BUT A BIOLOX DELTA 28 MM +3 MM FEMORAL HEAD. THE USE OF A FEMORAL HEAD WITH A +3 MM OFFSET, WHEN COMPARED TO THE PREVIOUS TWO FEMORAL HEADS WITH A -3 MM OFFSET, SUGGESTS AN ATTEMPT TO COMPENSATE FOR JOINT LAXITY BY POSITIONING THE FEMORAL STEM MORE LATERALLY. NO ROOT CAUSE CAN BE IDENTIFIED AS THE COMPLAINT HAS NOT BEEN CONFIRMED, THE VISUAL INSPECTION SHOWS THE HEAD IS STILL LOCATED IN THE ACT ARTIC E1 HIP BEARING (ITEM: EP-200152, LOT: 530950) THEREFORE IT IS UNLIKELY TO HAVE CAUSED THE DISLOCATION, HOWEVER THIS CANNOT BE CONFIRMED WITH THE INFORMATION PROVIDED. A REVIEW OF THE COMPLAINTS DATABASE SHOWS THAT WE HAVE RECEIVED 2 REPORTED EVENTS FOR DISLOCATION FOR THE SAME ITEM NUMBER 650-1159 PRIOR TO THE REPORTED EVENT. RISK ASSESSMENT: -THE SEVERITY ASSOCIATED WITH THE ABOVE LINE IS 3. -THIS GIVES A SEVERITY SCORE OF S-3 (MODERATE) AS PER THE RMR. -THE ACTUAL SEVERITY SCORE IS 3 (NEGLIGIBLE) IN LINE WITH THE RISK TABLE. OCCURRENCE RATE ASSESSMENT: -NOVEMBER 2017 TO NOVEMBER 2020: (B)(4) ITEMS SOLD. -NUMBER OF SIMILAR INCIDENTS IDENTIFIED: 3 (INCLUDING INITIATING COMPLAINT). -OCCURRENCE RATIO: (B)(4). RISK SCORE: -SEVERITY 3 X OCCURRENCE = 9 (MEDIUM RISK). RISK ASSESSMENT SUMMARY: THE SEVERITY OF THE REPORTED EVENT AND CALCULATED OCCURRENCE FOR SIMILAR COMPLAINTS ARE IN LINE WITH THE RISK FILE THE OVERALL SCORE IS MEDIUM RISK. NO CORRECTIVE OR PREVENTIVE ACTION IS CONSIDERED NECESSARY AT THIS TIME. 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 · 0

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2020 FOR FEMORAL NECK FRACTURE DUE TO A FALL OF PARKINSON DISEASE. THE POSTOPERATIVE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 DUE TO DISLOCATION. THE PATIENT UNDERWENT ANOTHER REVISION SURGERY ON (B)(6) 2020 DUE TO DISLOCATION. FINALLY, AFTER AN EXPLORATORY INCISION, THE DOCTOR FOUND THAT THE LARGE AND SMALL HEADS WERE SEPARATED. THE DOCTOR THINKS THAT THERE IS SOMETHING WRONG WITH THE LOCKING MECHANISM OF THE PRODUCT, WHICH ALSO BRINGS GREAT TROUBLE TO THE PATIENT AND FINANCIAL BURDEN. INITIAL SURGERY PRODUCT: -LOT# 925640 ITEM# 192413; -LOT# 708550 ITEM# US157852; -LOT# 530950 ITEM# EP-200152; -LOT# 201910612, ITEM# 650-1159. 1ST REVISION SURGERY: -LOT# 530950 ITEM# EP-200152; -LOT# 201910612, ITEM# 650-1159. 2ND REVISION SURGERY: -LOT# 530960, ITEM# EP-200152; -LOT# 2018111500, ITEM# 650-1157. REPORTABLE INCIDENT: SECOND REVISION DUE TO DISLOCATION.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. CUSTOMER HAS INDICATED THAT THE PRODUCT IS AVAILABLE TO BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: ACT ARTIC E1 HIP BRG 28X46MM, CATALOG #: EP-200152, LOT #: 530950. (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2020 FOR FEMORAL NECK FRACTURE DUE TO A FALL OF PARKINSON DISEASE. THE POSTOPERATIVE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 DUE TO DISLOCATION. THE PATIENT UNDERWENT ANOTHER REVISION SURGERY ON (B)(6) ,2020 DUE TO DISLOCATION. FINALLY, AFTER AN EXPLORATORY INCISION, THE DOCTOR FOUND THAT THE LARGE AND SMALL HEADS WERE SEPARATED. THE DOCTOR THINKS THAT THERE IS SOMETHING WRONG WITH THE LOCKING MECHANISM OF THE PRODUCT, WHICH ALSO BRINGS GREAT TROUBLE TO THE PATIENT AND FINANCIAL BURDEN. INITIAL SURGERY PRODUCT: -LOT# 925640 ITEM# 192413. -LOT# 708550 ITEM# US157852. -LOT# 530950 ITEM# EP-200152. -LOT# 201910612, ITEM# 650-1159. 1ST REVISION SURGERY: -LOT# 530950 ITEM# EP-200152. -LOT# 201910612, ITEM# 650-1159. 2ND REVISION SURGERY: -LOT# 530960, ITEM# EP-200152. -LOT# 2018111500, ITEM# 650-1157. REPORTABLE INCIDENT: SECOND REVISION DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1478093 DELTA CER FEM HD 28/-3MM T1 CERAMIC FEMORAL HEAD PROSTHESIS OQG BIOMET UK LTD. N/A 2019102612

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R