NA 02.231.670Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982062895), received between Nov 9, 2021 and May 16, 2023 — classified as 6 injuries.

2 other recalls cover devices cleared under the same FDA submission (K110354); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY WITH DISTAL REPLACEMENT. HARDWARE REMOVAL LEFT FEMUR DUE TO LEFT SUPRACONDYLAR/INTERCONDYLAR FEMORAL FRACTURE NONUNION, HARDWARE FAILURE AND OSTEOARTHRITIS LEFT KNEE. ON (B)(6) 2021, THE PATIENT UNDERWENT LEFT DISTAL FEMUR OPEN REDUCTION AND INTERNAL FIXATION WITH A SYNTHES LATERAL PLATE AND MULTIPLE CERCLAGE CABLES DUE TO LEFT DISTAL FEMUR COMMINUTED INTRA-ARTICULAR FRACTURE AND MORBID OBESITY. IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT HAD A FALL. SHE WAS CLIMBING OVER SOMETHING LIKE A DOG GATE, TRIPPED AND FELL. SHE INITIALLY FELT PAIN IN HER LEFT KNEE. SHE WAS DIAGNOSED WITH A LEFT DISTAL FEMUR FRACTURE. THIS COMPLAINT INVOLVES (18) DEVICES. THIS REPORT IS FOR ONE (1) 5.0MM CANNULATED VA LOCKING SCREW/70MM. THIS REPORT IS FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 16940292 ↗
• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY WITH DISTAL REPLACEMENT. HARDWARE REMOVAL LEFT FEMUR DUE TO LEFT SUPRACONDYLAR/INTERCONDYLAR FEMORAL FRACTURE NONUNION, HARDWARE FAILURE AND OSTEOARTHRITIS LEFT KNEE. ON (B)(6) 2021 THE PATIENT UNDERWENT LEFT DISTAL FEMUR OPEN REDUCTION AND INTERNAL FIXATION WITH A SYNTHES LATERAL PLATE AND MULTIPLE CERCLAGE CABLES DUE TO LEFT DISTAL FEMUR COMMINUTED INTRA-ARTICULAR FRACTURE AND MORBID OBESITY. IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT HAD A FALL. SHE WAS CLIMBING OVER SOMETHING LIKE A DOG GATE, TRIPPED AND FELL. SHE INITIALLY FELT PAIN IN HER LEFT KNEE. SHE WAS DIAGNOSED WITH A LEFT DISTAL FEMUR FRACTURE. THIS COMPLAINT INVOLVES (18) DEVICES. THIS REPORT IS FOR ONE (1) 5.0MM CANNULATED VA LOCKING SCREW/70MM THIS REPORT IS FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 16940211 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON SEPTEMBER 24, 2020 THE PATIENT HAD A FALL AND SUSTAINED A PERIPROSTHETIC FEMUR FRACTURE REQUIRING OPEN REDUCTION INTERNAL FIXATION (ORIF). THE PLATE AND SCREWS WERE MANUFACTURED BY SYNTHES. IMPLANTS DID NOT APPEAR TO BE REMOVED. ON (B)(6), 2021 X-RAY TAKEN SHOWED PERSISTENT DISPLACEMENT OF A PARTIALLY HEALED DISTAL FEMUR FRACTURE WITH LATERAL PLATE AND SCREW CONSTRUCT STABLE IN POSITION. ON (B)(6), 2021 INJECTION TO LEFT KNEE FOR PAIN PERFORMED. PAIN HAS PERSISTED DESPITE PHYSICAL THERAPY, BRACING, AND NERVE BLOCKS. ON (B)(6), 2021: SURGEON STATEED THAT THE LEFT KNEE IS LIGAMENTOUSLY LOOSE TO VARUS STRESS AND PAIN ON (B)(6), 2021 X-RAY RESULTS STATED THAT THERE IS A PERIPROSTHETIC FRACTURE IN THE DISTAL FEMORAL DIAPHYSIS THAT IS SUBACUTE TO CHRONIC. THERE IS ONE SHAFT WIDTH POSTERIOR DISPLACEMENT OF THE DISTAL FRACTURE FRAGMENT. THERE IS NO EVIDENCE OF HARDWARE FRACTURE OR LOOSENING. SURGEON STATES LEFT KNEE IS UNSTABLE LIKELY SECONDARY TO MALUNION OF THE FEMUR FRACTURE WITH RESULTANT SHORTENING. ON (B)(6) 2021: PATIENT SUSTAINED TWO FALLS RESULTING IN A PELVIC AND THEN A RIGHT HUMERAL FRACTURE. MEDICAL RECORDS DO NOT INCLUDE THE PRIMARY OPERATIVE NOTES, NOR

  Patient problems: Bone Fracture(s); Malunion of Bone; Pain

  MAUDE report 16747881 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY WITH DISTAL REPLACEMENT. HARDWARE REMOVAL LEFT FEMUR DUE TO LEFT SUPRACONDYLAR/INTERCONDYLAR FEMORAL FRACTURE NONUNION, HARDWARE FAILURE AND OSTEOARTHRITIS LEFT KNEE. ON (B)(6) 2021 THE PATIENT UNDERWENT LEFT DISTAL FEMUR OPEN REDUCTION AND INTERNAL FIXATION WITH A SYNTHES LATERAL PLATE AND MULTIPLE CERCLAGE CABLES DUE TO LEFT DISTAL FEMUR COMMINUTED INTRA-ARTICULAR FRACTURE AND MORBID OBESITY. IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT HAD A FALL. SHE WAS CLIMBING OVER SOMETHING LIKE A DOG GATE, TRIPPED AND FELL. SHE INITIALLY FELT PAIN IN HER LEFT KNEE. SHE WAS DIAGNOSED WITH A LEFT DISTAL FEMUR FRACTURE. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR ONE (1) 5.0MM CANNULATED VA LOCKING SCREW/70MM THIS IS REPORT 2 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 16723784 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT UNDERWENT A REMOVAL OF HARDWARE FROM DISTAL FEMUR DUE TO PAIN. THERE WAS NO SURGICAL DELAY NOTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 5.0MM CANNULATED VA LOCKING SCREW/70MM. THIS IS REPORT 7 OF 10 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12779844 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT UNDERWENT A REMOVAL OF HARDWARE FROM DISTAL FEMUR DUE TO PAIN. THERE WAS NO SURGICAL DELAY NOTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 5.0MM CANNULATED VA LOCKING SCREW/70MM. THIS IS REPORT 3 OF 10 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12779824 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110354. One submission often covers many models, so check the product and lot details in each record.

• Z-1125-2014 · Feb 5, 2014 · Terminated
  Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plat
• Z-0401-2014 · May 29, 2013 · Terminated
  Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fra