BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 7645468 · Received June 28, 2018

    Report

    Report Number
    8030965-2018-54682
    Event Type
    Injury
    Date Received
    June 28, 2018
    Date of Event
    May 25, 2017
    Report Date
    June 18, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: H6: CODE 3191 USED TO CAPTURE REQUIRED SURGICAL INTERVENTION. H11 CORRECTED DATA: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    SIXTEEN PATIENTS (8 MALE AND 8 FEMALE) WITH MEAN AGE OF 61 ± 17 YEARS. UNKNOWN DATE OF EVENT, MAY 25, 2017 IS WHEN THE ARTICLE WAS PUBLISHED. THE 510K: THIS REPORT IS FOR AN UNKNOWN DISTAL SCREW/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. [(B)(4).PDF].

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: HODEL, S., BEERES, FJP., BABST, R. AND LINK. B. (2017), COMPLICATIONS FOLLOWING PROXIMAL FEMORAL LOCKING COMPRESSION PLATING IN UNSTABLE PROXIMAL FEMUR FRACTURES: MEDIUM-TERM FOLLOW-UP, EUROPEAN JOURNAL OF ORTHOPAEDIC SURGERY & TRAUMATOLOGY, VOL. 27, PAGES 1117-1124 (FRANCE). THE PURPOSE OF THIS RETROSPECTIVE STUDY IS TO ASSESS THE OUTCOME OF THE PATIENTS, WHO SUSTAINED A SUBTROCHANTERIC OR INTER-/PERTROCHANTERIC FEMUR FRACTURE AND WERE TREATED WITH A PROXIMAL FEMUR-LOCKING COMPRESSION PLATE (PF-LCP). BETWEEN 2011 AND 2015, 16 PATIENTS (8 MALE AND 8 FEMALE) WITH MEAN AGE OF 61 ± 17 YEARS WERE TREATED WITH PROXIMAL FEMUR LOCKING COMPRESSION PLATE (PFLCP). PRIMARY ENDPOINTS WERE DEFINED AS RADIOLOGICAL FRACTURE HEALING (UNION, DELAYED-UNION OR NON-UNION), POST-OPERATIVE AMBULATORY STATUS AND POST-OPERATIVE COMPLICATIONS. FRACTURE UNION WAS DEFINED AS RADIOLOGICAL SIGNS OF FRACTURE HEALING IN THREE OUT OF FOUR CORTICES IN CONVENTIONAL RADIOGRAPHY OR CONSOLIDATION IN COMPUTED TOMOGRAPHY. DELAYED-UNION WAS DEFINED AS MISSING RADIOLOGICAL FRACTURE HEALING AFTER 6 MONTHS OR NO PROGRESSIVE SIGNS OF FRACTURE HEALING IN BETWEEN THE THREE- AND 6 MONTH CONTROLS. NON-UNION WAS DEFINED AS MISSING RADIOLOGICAL FRACTURE HEALING AFTER 9 MONTHS OR NO SIGNS OF PROGRESSION OF FRACTURE HEALING IN BETWEEN THE THREE- AND 6 MONTH CONTROL. SECONDARY ENDPOINTS WERE TO ASSESS POTENTIAL RISK FACTORS FOR DELAYED FRACTURE HEALING, POST-OPERATIVE COMPLICATIONS AND THE TIME OF FULL WEIGHT BEARING. PATIENTS WERE ALLOWED FOR PARTIAL WEIGHT BEARING (15-20KG) FROM THE SECOND POST-OPERATIVE DAY. CLINICAL AND RADIOLOGICAL FOLLOW-UP IS ROUTINELY PERFORMED 6 WEEKS, 3, 6 MONTHS AND 1 YEAR POST-OPERATIVE. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOW: TWO PATIENTS DIED WITHIN THE FOURTH POST-OPERATIVE WEEK (BOTH ASA-SCORE 4). ONE CASE OF DISPLACEMENT MEASURING <2 MM; ONE CASE OF DISPLACEMENT MEASURING 2-5 MM; ONE CASE OF DISPLACEMENT MEASURING >5 MM; TWO OTHER CASES OF IMPLANT-ASSOCIATED MALROTATION AND SYMPTOMATIC IMPINGEMENT OF THE HIP OCCURRED. THE MALROTATION WAS SURGICALLY CORRECTED AFTER 5 DAYS OF THE INDEX SURGERY, AND REFIXATION WAS PERFORMED USING THE SAME PF-LCP. THE SYMPTOMATIC IMPINGEMENT DID NOT UNDERGO SURGERY BECAUSE OF ONLY MINOR SYMPTOMS. A (B)(6) PATIENT WITH A REVERSED INTERTROCHANTERIC FRACTURE HAD UNEVENTFUL HEALING WITH FRACTURE CONSOLIDATION 3 MONTHS POST-OPERATIVE. A (B)(6) FEMALE PATIENT WITH A REVERSED INTERTROCHANTERIC FRACTURE UNDERWENT REVISION SURGERY WITH ADDITIONAL SCREW FIXATION DUE TO DISTAL SCREW FAILURE OR FRACTURES 5 WEEKS AFTER SURGERY. A (B)(6) MALE PATIENT WITH A HISTORY OF FALL (LOW ENERGY) HAD TO BE REVISED WITH AN ANGLED-BLADE PLATE AFTER 5 DAYS DUE TO MALPOSITIONING AND INADEQUATE REDUCTION. DUE TO A NON-UNION A TOTAL HIP REPLACEMENT WAS SUCCESSFULLY PERFORMED 6 MONTHS AFTER THE INITIAL TRAUMA. AN (B)(6) MALE PATIENT WITH A HISTORY OF FALL (LOW ENERGY) HAD IMPLANT-ASSOCIATED LATE INFECTION LED TO REMOVAL OF THE PLATE, RECURRING DEBRIDEMENT AND IMPLANTATION OF ANTIBIOTIC SPACER. INTRAOPERATIVE, A STABLE SITUATION WAS FOUND WHICH INDICATED A CONSOLIDATED FRACTURE, AND NO FURTHER FIXATION WAS PERFORMED. AFTER REMOVAL OF THE ANTIBIOTIC SPACER THE PATIENT WENT BACK TO AMBULATORY STATUS WITH A WHEELED WALKER 1 YEAR POST-OPERATIVELY. A (B)(6) MALE PATIENT WITH MVA (HIGH ENERGY) HAD MALROTATION REQUIRED BONE ALLOGRAFT AND PLATE RELOCATION. A (B)(6) FEMALE PATIENT WITH A HISTORY OF SPORTS (HIGH ENERGY) HAD POST-TRAUMATIC IMPINGEMENT OF THE HIP WITH NO FURTHER TREATMENT. THIS REPORT IS FOR AN UNKNOWN DISTAL SCREW. THIS REPORT IS TO CAPTURE: A (B)(6) FEMALE PATIENT WITH A REVERSED INTERTROCHANTERIC FRACTURE UNDERWENT REVISION SURGERY WITH ADDITIONAL SCREW FIXATION DUE TO DISTAL SCREW FAILURE OR FRACTURES 5 WEEKS AFTER SURGERY. THIS IS REPORT 2 OF 6 FOR (B)(4). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487162 SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention