BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: TRAUMA

    MDR report key: 9413782 · Received December 4, 2019

    Report

    Report Number
    8030965-2019-70775
    Event Type
    Injury
    Date Received
    December 4, 2019
    Report Date
    November 13, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN TRAUMA SCREW. PART AND LOT NUMBERS 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. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: BOESMUELLER, S., BAUMBACH, S.F., HOFBAUER, M., AND WOZASEK, G. (2015), PLATE FAILURE FOLLOWING PLATE OSTEOSYNTHESIS IN PERIPROSTHETIC FEMORAL FRACTURES, WIENER KLINISCHE WOCHENSCHRIFT, VOL. 127 (ISSUE 19-20), PAGES 770-778, DOI 10.1007/S00508-015-0818-3 (AUSTRIA). THE OBJECTIVE OF THIS RETROSPECTIVE STUDY WAS TO INVESTIGATE ALL PATIENTS WITHIN THE PAST 10 YEARS REQUIRING PLATE OSTEOSYNTHESIS FOLLOWING A PERIPROSTHETIC FEMORAL FRACTURES (PPFF). SEVEN FEMALE PATIENTS WITH AVERAGE AGE OF 74 YEARS (RANGE, 49¿88 YEARS) AT INITIAL SURGERY WERE INCLUDED IN THE STUDY. ALL UNDERWENT PLATE OSTEOSYNTHESIS FOLLOWING PPFF BETWEEN JANUARY 2000 AND JUNE 2010 AND EXPERIENCED PLATE FAILURE. FOUR PATIENTS HAD A PPFF AFTER TOTAL HIP ARTHROPLASTY (THA) AND THREE AFTER TOTAL KNEE ARTHROPLASTY (TKA). MEAN FOLLOW-UP FROM INITIAL PRESENTATION TO FINAL VISIT WAS 885 DAYS (RANGE, 264 2549). PATIENT 3 (TKA) HAD NONHEALING OF THE BONE THAT FORCED THE PLATE BREAKAGE OF THE LESS INVASIVE STABILIZATION SYSTEM (LISS) PLATE (DEPUY SYNTHES, VIENNA, AUSTRIA) 8 MONTHS AFTER INITIAL SURGERY. IMPLANT REMOVAL AND THOROUGH DEBRIDEMENT WAS PERFORMED AND A 9-HOLE LC-DCP WAS APPLIED AND CANCELLOUS BONE GRAFT FROM THE ILIAC CREST MIXED WITH OSTEOGENIC PROTEIN-1/BONE MORPHOGENETIC PROTEIN AND BONE CEMENT WAS ADDED. PATIENT 5 (THA) EXPERIENCED PLATE FAILURE AND HAD IMPLANT REMOVAL. THE BONE WAS DEBRIDED AND FIXED WITH A 17-HOLE TITANIUM LC-DCP (DEPUY SYNTHES, VIENNA, AUSTRIA) PLUS AUTOLOGOUS BONE GRAFT (ILIAC CREST) AND ISOBONE (DEPUY ORTHOPAEDICS, INC., WARSAW, IN 46582). AFTER 5 MONTHS, MULTIPLE SCREW BREAKAGE WAS NOTED RADIOGRAPHICALLY AND 1 MONTH LATER THE PERSISTENT PSEUDARTHROSIS WAS REPLATED FOR THE SECOND TIME. A CEMENT-SCREW CONSTRUCT WAS ALSO PERFORMED. PATIENT 6 (THA) HAD REPLATING WITH A PACKED DOUBLE PLATING USING A 22-HOLE LOCKING COMPRESSION PLATE (LCP), TOPPED BY A SECOND 12-HOLE LCP (DEPUY SYNTHES, VIENNA, AUSTRIA). AFTER 4 MONTHS, THE PATIENT AGAIN EXPERIENCED PAIN IN THE RIGHT THIGH. RADIOGRAPHS REVEALED A FEMORAL SHAFT FRACTURE WITH PLATE BREAKAGE OF BOTH PLATES. SURGERY WAS PERFORMED USING A 12 × 240 MM CEMENTLESS LONG-STEM PROSTHESIS, AUTOLOGOUS CANCELLOUS BONE GRAFT (ILIAC CREST) MIXED WITH OP-1/BMP-7 AND APPLICATION OF THREE TITANIUM CERCLAGES. PATIENT 7 (TKA) HAD REPLATING USING A PACKED DOUBLE-PLATING WITH A 13-HOLE LCP TOPPED BY A 9-HOLE LCP (DEPUY SYNTHES, VIENNA, AUSTRIA). A LONG LEG CAST WAS APPLIED FOR 10 WEEKS. AFTER 6 MONTHS, THE PATIENT AGAIN EXPERIENCED INCREASING RIGHT THIGH PAIN. THE RADIOGRAPHS REVEALED BREAKAGE OF THE BASE PLATE AND LOOSENING OF THE THREE PROXIMAL SCREWS. SECOND REPLATING WAS PERFORMED WITH A 14-HOLE PLUS 12-HOLE TITANIUM LC-DCP (DEPUY SYNTHES, VIENNA, AUSTRIA). IN CONCLUSION, THE AUTHORS REPORTED THAT IN PATIENTS WITH POOR BONE QUALITY, BONE GRAFT, BONE CEMENT, AND BONE BIOLOGICS HAVE TO BE CONSIDERED IN REVISION SURGERY. PATIENT(S) INFO: LESS INVASIVE STABILIZATION SYSTEM (LISS) PLATE (DEPUY SYNTHES, VIENNA, AUSTRIA) - [PATIENT 3 (TKA)] PLATE BREAKAGE. 17-HOLE TITANIUM LC-DCP (DEPUY SYNTHES, VIENNA, AUSTRIA) ¿ [PATIENT 5 (THA)] ISOBONE (DEPUY ORTHOPAEDICS, INC., WARSAW, IN 46582) MULTIPLE SCREW BREAKAGE. PSEUDARTHROSIS. 22-HOLE LOCKING COMPRESSION PLATE (LCP)- [PATIENT 6 (THA)] 12-HOLE LCP (DEPUY SYNTHES, VIENNA, AUSTRIA) PAIN IN THE RIGHT THIGH. FEMORAL SHAFT FRACTURE. PLATE BREAKAGE OF BOTH PLATES. 13-HOLE LCP - [PATIENT 7 (TKA)] 9-HOLE LCP (DEPUY SYNTHES, VIENNA, AUSTRIA) RIGHT THIGH PAIN. BREAKAGE OF THE BASE PLATE. LOOSENING OF THE THREE PROXIMAL SCREWS. TREATMENT NOTED: TREATMENT FOR PATIENT 3 (TKA): PLATE BREAKAGE REQUIRED IMPLANT REMOVAL AND THOROUGH DEBRIDEMENT. A 9-HOLE LC-DCP WAS APPLIED AND CANCELLOUS BONE GRAFT FROM THE ILIAC CREST MIXED WITH OSTEOGENIC PROTEIN-1/BONE MORPHOGENETIC PROTEIN AND BONE CEMENT WAS ADDED. TREATMENT FOR PATIENT 5 (THA): MULTIPLE SCREW BREAKAGE AND PERSISTENT PSEUDARTHROSIS REQUIRED REPLATING AND A CEMENT-SCREW CONSTRUCT WAS PERFORMED. TREATMENT FOR PATIENT 6 (THA): PAIN IN THE RIGHT THIGH, FEMORAL SHAFT FRACTURE, AND PLATE BREAKAGE OF BOTH PLATES REQUIRED SURGERY USING A 12 × 240 MM CEMENTLESS LONG-STEM PROSTHESIS, AUTOLOGOUS CANCELLOUS BONE GRAFT (ILIAC CREST) MIXED WITH OP-1/BMP-7 AND APPLICATION OF THREE TITANIUM CERCLAGES. TREATMENT FOR PATIENT 7 (TKA): RIGHT THIGH PAIN, BREAKAGE OF THE BASE PLATE AND LOOSENING OF THE THREE PROXIMAL SCREWS REQUIRED REPLATING USING A 14-HOLE PLUS 12-HOLE TITANIUM LC-DCP (DEPUY SYNTHES, VIENNA, AUSTRIA). THIS REPORT IS FOR AN UNKNOWN SYNTHES LISS PLATES, UNKNOWN SYNTHES PLATE AND SCREWS CONSTRUCT AND UNKNOWN SYNTHES PLATES AND UNKNOWN SYNTHES SCREWS. THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS FOR ONE (1) UNKNOWN TRAUMA SCREW. THIS IMPACTED PRODUCT CAPTURES THE REPORTED (B)(6)-YEAR-OLD FEMALE PATIENT WHO HAD MULTIPLE SCREW BREAKAGE. THIS IS REPORT 2 OF 9 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205375 UNK - SCREWS: TRAUMA PLATE,FIXATION,BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention