NA 02.231.260Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982062192), received between Jul 23, 2020 and Jul 21, 2022 — classified as 10 injuries.

The most frequently reported specific device problem is “Device Slipped” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K083025, 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GREAT BRITAIN AS FOLLOWS: PATIENT SUSTAINED PERIPROSTHETIC FRACTURE (PPF) BELOW FEMORAL NAIL IN MARCH AND WAS FIXED WITH VA CONDYLAR PLATE ON AN UNKNOWN DATE IN MARCH 2022. PATIENT WAS READMITTED APPROXIMATELY 3 MONTHS AFTER IMPLANT WITH PLATE FRACTURE. NO NEW TRAUMA. HAD BEEN MOBILIZING IN RESIDENTIAL HOME. NORMAL TO LOW BMI. FRACTURE NON-UNITED, BUT NO EVIDENCE OF INFECTION. REVISION OCCURRED (B)(6) 2022. THIS IS REPORT 7 OF 11 FOR (B)(4). THIS REPORT IS FOR A LOCKING SCREW. THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15077703 ↗
• InjuryMar 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 AFTER THE SURGERY DURING THE REMOVAL OF VALCP CURVED CONDYLAR PLATE, SCREWS, AND A ZIMMER RETROGRADE NAIL DUE TO INFECTION AND NONUNION. PATIENT¿S PREVIOUS BELOW KNEE AMPUTATION WAS REVISED TO AN ABOVE KNEE AMPUTATION. THE PATIENT EXPERIENCED NO POST-OP DEVICE MALFUNCTION. THIS COMPLAINT INVOLVES TWELVE (12) DEVICES.

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 13839775 ↗
• InjuryMar 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 AFTER THE SURGERY DURING THE REMOVAL OF VALCP CURVED CONDYLAR PLATE, SCREWS, AND A ZIMMER RETROGRADE NAIL DUE TO INFECTION AND NONUNION. PATIENT¿S PREVIOUS BELOW KNEE AMPUTATION WAS REVISED TO AN ABOVE KNEE AMPUTATION. THE PATIENT EXPERIENCED NO POST-OP DEVICE MALFUNCTION. THIS COMPLAINT INVOLVES TWELVE (12) DEVICES.

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 13839774 ↗
• InjuryMar 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 AFTER THE SURGERY DURING THE REMOVAL OF VALCP CURVED CONDYLAR PLATE, SCREWS, AND A ZIMMER RETROGRADE NAIL DUE TO INFECTION AND NONUNION. PATIENT¿S PREVIOUS BELOW KNEE AMPUTATION WAS REVISED TO AN ABOVE KNEE AMPUTATION. THE PATIENT EXPERIENCED NO POST-OP DEVICE MALFUNCTION. THIS COMPLAINT INVOLVES TWELVE (12) DEVICES.

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 13839772 ↗
• InjuryMar 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 AFTER THE SURGERY DURING THE REMOVAL OF VALCP CURVED CONDYLAR PLATE, SCREWS, AND A ZIMMER RETROGRADE NAIL DUE TO INFECTION AND NONUNION. PATIENT¿S PREVIOUS BELOW KNEE AMPUTATION WAS REVISED TO AN ABOVE KNEE AMPUTATION. THE PATIENT EXPERIENCED NO POST-OP DEVICE MALFUNCTION. THIS COMPLAINT INVOLVES TWELVE (12) DEVICES.

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 13839771 ↗
• InjuryMar 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 AFTER THE SURGERY DURING THE REMOVAL OF VALCP CURVED CONDYLAR PLATE, SCREWS, AND A ZIMMER RETROGRADE NAIL DUE TO INFECTION AND NONUNION. PATIENT¿S PREVIOUS BELOW KNEE AMPUTATION WAS REVISED TO AN ABOVE KNEE AMPUTATION. THE PATIENT EXPERIENCED NO POST-OP DEVICE MALFUNCTION. THIS COMPLAINT INVOLVES TWELVE (12) DEVICES.

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 13839769 ↗
• InjuryMar 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 AFTER THE SURGERY DURING THE REMOVAL OF VALCP CURVED CONDYLAR PLATE, SCREWS, AND A ZIMMER RETROGRADE NAIL DUE TO INFECTION AND NONUNION. PATIENT¿S PREVIOUS BELOW KNEE AMPUTATION WAS REVISED TO AN ABOVE KNEE AMPUTATION. THE PATIENT EXPERIENCED NO POST-OP DEVICE MALFUNCTION. THIS COMPLAINT INVOLVES TWELVE (12) DEVICES.

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 13839766 ↗
• InjuryMar 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 AFTER THE SURGERY DURING THE REMOVAL OF VALCP CURVED CONDYLAR PLATE, SCREWS, AND A ZIMMER RETROGRADE NAIL DUE TO INFECTION AND NONUNION. PATIENT¿S PREVIOUS BELOW KNEE AMPUTATION WAS REVISED TO AN ABOVE KNEE AMPUTATION. THE PATIENT EXPERIENCED NO POST-OP DEVICE MALFUNCTION. THIS COMPLAINT INVOLVES TWELVE (12) DEVICES.

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 13839757 ↗
• InjuryAug 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL EVENT DESCRIPTION: ON 10/04/2019, A CLINIC REPORTED THAT PATIENT HAD A RECENT FALL, AND SUSTAINED A DISPLACED FRACTURE DISTAL TIP. PAIN LEVEL IS 4/10. ON (B)(6) 2019, PROGRESS NOTE REPORTED THAT A FRACTURE PLATE AT THE SITE OF PREVIOUS FRACTURE.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12308609 ↗
• InjuryJul 23, 2020Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THAT THE PATIENT UNDERWENT THE REMOVAL OF OSTEOSYNTHESIS MATERIAL AND A CONDYLAR SUPPORT PLATE THAT HAD FAILED. THE DISTAL LOCKING SCREWS OF THE PLATE WERE LOOSE AND ONE WAS ALREADY EXPOSED OUTSIDE OF THE SKIN. AN ADDITIONAL REDUCTION WAS PERFORMED BUT THE SCREWS DID NOT BLOCK THE PLATE AND IT WAS DECIDED TO REMOVE ALL THE MATERIAL AND PUT A SPLINT IN ONE OF THE WOUNDS THAT WAS FOUND TO BE INFECTED. THE FIRST INTERVENTION WAS PERFORMED BECAUSE THE DISTAL SCREWS OF THE PLATE CAME OFF. THE SECOND OPERATION WAS PERFORMED TO EXTRACT A SCREW THAT WAS EXPOSED THROUGH THE SKIN AND THE THIRD INTERVENTION WAS WHEN ALL OF THE MATERIAL WAS REMOVED. THE FIRST TWO INTERVENTIONS WERE PERFORMED TO REMOVE THE IMPLANT AND TRY TO CORRECT THE NEW FRACTURE, IN THE LAST SURGERY IT WAS SHOWN THAT THERE WAS AN INFECTION. THIS REPORT IS FOR ONE (1) 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/60MM. THIS IS REPORT 4 OF 9 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10312728 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083025, 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