LCP 226.622Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982159168), received between Feb 8, 2017 and May 9, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K000682, K041911, K082807); 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 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT #85: 73-YEAR-OLD FEMALE WAS IMPLANTED WITH LCP BROAD, CURVED PLATES 4.5/5.0 (226.622) IN FEMUR WITH DPS SCREWS (UNKNOWN QUANTITY) WITH NO ADJUNCTIVE FIXATION. POST-OPERATIVE COMPLICATION: DIMINISHED ROM EXPERIENCED 1 WEEKS POST-OP RELATED TO SYNTHES DEVICE. TREATMENT: SURGICAL TREATMENT FOR HARDWARE REMOVAL PERFORMED FOR REMOVAL OF ALL HARDWARE 12 WEEKS POST-OP. OUTCOME: RECOVERED/RESOLVED WITH SEQUELAE THIS REPORT IS FOR A 4.5MM CURVED BROAD LCP® PLATE 12 HOLES/229MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Loss of Range of Motion

  MAUDE report 19280219 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT HARDWARE REMOVAL OF A RIGHT FEMUR FOR OSTEOMYELITIS INFECTION. THE ORIGINAL DATE OF SURGERY WAS (B)(6) 2019. ALL HARDWARE WAS REMOVED EASILY. THERE WAS (1) POSTOPERATIVELY BROKEN SCREW. NO FRAGMENTS WERE GENERATED FROM THE BROKEN IMPLANT. THERE WAS NO SURGICAL DELAY REPORTED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR (1) 4.5MM CURVED BROAD LCP PLATE 12 HOLES/229MM. THIS IS REPORT 5 OF 15 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12088485 ↗
• InjuryMay 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD AN ORIGINAL OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A PERIPROSTHETIC FRACTURE OF TOTAL HIP STEM ON (B)(6) 2018. A LONG BROAD CURVED PLATE WAS USED WITH CABLES TO FIX THE FRACTURE. PATIENT LATER SUFFERED A NEW FRACTURE DISTAL TO THE PLATE AND THE SURGEON REVISED THE ORIGINAL PLATE BY REMOVING IT AND REPLACING IT WITH A 4.5 VA-LCP CURVED CONDYLAR PLATE AND CABLES ON (B)(6) 2018. THE ORIGINAL CONSTRUCT DID NOT FAIL. IT WAS REMOVED TO REVISE TO A NEW PLATE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT DISPOSITION IS UNKNOWN. THIS REPORT IS FOR A 4.5MM CURVED BROAD LCP® PLATE 12 HOLES/229MM. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 7486502 ↗
• InjuryApr 6, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY IN (B)(6) 2017 DUE TO LOOSE WIRES AND SCREWS (UNKNOWN MANUFACTURER). IN (B)(6) 2018, IT WAS DETERMINED THE PATIENT'S SYNTHES PLATE SNAPPED IN HALF AND SHE HAD TO HAVE ADDITIONAL SURGERY FOR ALL NEW HARDWARE TO BE IMPLANTED. SHE WAS USING A WALKER AND ONLY PARTIAL WEIGHT BEARING ON THAT LEG. THE PATIENT ORIGINALLY FRACTURED LEFT FEMUR IN (B)(6) 2017. THE DEVICES WERE ORIGINALLY IMPLANTED DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF HER LEFT FEMUR IN (B)(6) 2017. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 7403645 ↗
• InjuryDec 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON (B)(6) 2017 DUE TO SECONDARY FRACTURE AND FRACTURE DISPLACEMENT OF A DISTAL FEMUR FRACTURE. THE ORIGINAL SURGERY OCCURRED ON (B)(6) 2017 AND WAS AN OPEN REDUCTION AND INTERNAL FIXATION PERIPROSTHETIC FEMUR FRACTURE. A TOTAL KNEE WITH A NON-SYNTHES IMPLANT WAS OCCURRED ON (B)(6) 2017, WHEN A FRACTURE OF THE FEMUR BONE OCCURRED DURING THE IMPLANT OF THE TOTAL KNEE DEVICE. THIS INTRAOPERATIVE FRACTURE WAS REPAIRED WITH ONE (1) 12 HOLE-BROAD PLATE, SIX (6) 0.5MM LOCKING SCREWS AND ONE (1) 4.5 CORTEX SCREWS. POST-OPERATIVELY ON AN UNKNOWN DATE THE PATIENT FELL AND IT WAS DETERMINED THAT THE FEMUR FRACTURE HAD RE-FRACTURED AND BECOME DISPLACED. ALL SYNTHES HARDWARE WAS INTACT AND REMOVED SUCCESSFULLY. THE NON-SYNTHES IMPLANT WAS NOT REMOVED. THE PATIENT WAS REVISED TO A PERIPROSTHETIC PLATE, TWO (2) LOCKING ATTACHMENT PLATES, AND AN UNKNOWN NUMBER OF SCREWS. NO SURGICAL DELAY WAS REPORTED FOR THE REVISION. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES: NON-SYNTHES IMPLANT (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1) . THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 7084360 ↗
• InjuryFeb 8, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THE PATIENT HAD AN ANGULATED LEG, NONUNION, AND PLATE BREAKAGE WHICH REQUIRED REVISION SURGERY. THE PATIENT WAS INITIALLY IMPLANTED WITH ONE (1) 4.5MM CURVED BROAD LOCKING COMPRESSION PLATE (LCP) 12 HOLES/229MM AND UNKNOWN QUANTITY OF LOCKING SCREWS AND CORTICAL SCREWS APPROXIMATELY FOUR WEEKS PRIOR TO THE DATE OF THIS REPORT (EXACT DATE IS UNKNOWN). THE PATIENT WAS NON-COMPLIANT AND WALKED ON HER LEG. THE PATIENT THEN NOTICED HER LEG WAS ANGULATED. THE PATIENT DID NOT REPORT ANY PAIN AND CAME BACK FOR A NON-ROUTINE VISIT ON (B)(6) 2017. X-RAYS TAKEN DURING THE VISIT CONFIRMED THAT THE PLATE BROKE. THE PATIENT WAS REVISED ON (B)(6) 2017. THE DEVICES WERE EASILY REMOVED AND DID NOT REQUIRE ADDITIONAL MEDICAL INTERVENTION. THE SCREWS WERE REMOVED INTACT. NO FRAGMENTS GENERATED FROM THE BROKEN PLATE. THE PATIENT WAS REVISED TO A 4.5MM LCP CONDYLAR PLATE AND FEMORAL STRUT GRAFT WITH CABLES. THE REVISION SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAYS. THE PATIENT STATUS/OUTCOME WAS REPORTED AS UNSTABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN), UNKNOWN CORTICAL SCREWS (PART # UNKNOWN, LOT # UNKNO

  Patient problems: Failure of Implant; No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 6312862 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000682, K041911, K082807. One submission often covers many models, so check the product and lot details in each record.

• Z-0409-2014 · Jul 30, 2013 · Terminated
  Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures.