UNK - RESORBABLE IMPLANTS: MESH

Additional Manufacturer Narrative

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. THIS REPORT IS FOR AN UNKNOWN RESORBABLE IMPLANT: MESH UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW INVESTIGATION. INITIAL REPORTER IS A SYNTHES EMPLOYEE. 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.

Description of Event or Problem

THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: NICKOLAS J. NAHM, JANET D. CONWAY (2021)/RESORBABLE POLYLACTIDE MEMBRANE FOR THE TREATMENT OF SEGMENTAL BONE DEFECTS, INJURY 53, 376¿380 (USA). THIS RETROSPECTIVE STUDY AIMS TO PRESENT THE RESULTS OF THE TREATMENT OF SEGMENTAL BONE DEFECTS WITH RESORBABLE POLYLACTIDE MEMBRANE, BONE MORPHOGENIC PROTEIN-2 (BMP-2), AND AUTOGRAFT BY A SINGLE SURGEON FROM 2010 TO 2019. ELEVEN PATIENTS WITH MEDIAN AGE OF 37 YEARS (RANGE 22-62 YEARS) WERE INCLUDED IN THE STUDY WITH SEGMENTAL BONE DEFECTS IN THE TIBIA (N=3), FEMUR (N=4), OR FOREARM (N=4). MEDIAN BONE DEFECT SIZE WAS 6 CM (RANGE 3-12 CM). AT THE TIME OF RESORBABLE POLYLACTIDE MEMBRANE RECONSTRUCTION, THE BONE DEFECT WAS SUBPERIOSTEALLY EXPOSED. AUTOGRAFT WAS OBTAINED, TYPICALLY THROUGH THE REAMER/IRRIGATION/ASPIRATOR SYSTEM (DEPUY SYNTHES, WEST CHESTER, PA) FROM THE CONTRALATERAL FEMUR. MEDIAN RADIOGRAPH FOLLOW-UP WAS 24 MONTHS (RANGE 5-75 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: SEGMENTAL BONE DEFECTS HEALED IN 10 OF 11 PATIENTS AT A MEDIAN RANGE OF 1.3 YEARS (RANGE, 5 MONTHS TO 3.8 YEARS) 7 PATIENTS RETURNED TO THE OPERATING ROOM, WITH 6 PATIENTS REQUIRING FURTHER BONE GRAFTING AND 1 PATIENT WITH RECURRENCE OF OSTEOMYELITIS REQUIRING FURTHER DEBRIDEMENT. 1 PATIENT WITH OSTEOMYELITIS OF THE RADIUS AND ULNA DID NOT ACHIEVE HEALING OF THE BONE DEFECT. HOWEVER, THE PATIENT ONLY HAD 9 MONTHS OF RADIOGRAPHIC FOLLOW-UP AND REQUIRED RETURN TO THE OPERATING ROOM FOR REVISION OF INTRAMEDULLARY NAILING AND GRAFTING 7 MONTHS AFTER THE RESORBABLE POLYLACTIDE MEMBRANE BONE GRAFT CAGE. THIS PATIENT SUBSEQUENTLY REQUIRED SOFT-TISSUE COVERAGE WITH AN ABDOMINAL-BASED FLAP. THIS REPORT IS FOR AN UNK RESORBABLE IMPLANT: MESH. THIS IS REPORT 2 OF 2 FOR (B)(4).