LCP 241.361Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982166876), received between May 17, 2017 and May 9, 2024 — classified as 11 injuries.

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

2 other recalls cover devices cleared under the same FDA submission (K011335); 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2024Migration; Migration

  PATIENT #139: 65-YEAR-OLD MALE WAS IMPLANTED WITH LCP ONE-THIRD TUBULAR PLATES 3.5 (241.361) IN TIBIA WITH DPS SCREWS (UNKNOWN QUANTITY) WITH NO ADJUNCTIVE FIXATION. POST-OPERATIVE COMPLICATION: PROMINENT HARDWARE EXPERIENCED 12 WEEKS POST-OP RELATED TO SYNTHES DEVICE AND PROCEDURE. TREATMENT: SURGICAL TREATMENT FOR HARDWARE REMOVAL PERFORMED FOR REMOVAL OF ALL HARDWARE 30 WEEKS POST-OP. OUTCOME: RECOVERED/RESOLVED. THIS REPORT IS FOR A LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 6 HOLES/69MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19281271 ↗
• InjuryMay 9, 2024Migration; Migration

  PATIENT #133: 24-YEAR-OLD FEMALE WAS IMPLANTED WITH LCP ONE-THIRD TUBULAR PLATES 3.5 (241.361) IN FIBULA WITH DPS SCREWS (UNKNOWN QUANTITY) WITH NO ADJUNCTIVE FIXATION POST-OPERATIVE COMPLICATION: PROMINENT HARDWARE EXPERIENCED 24 WEEKS POST-OP RELATED TO SYNTHES DEVICE AND PROCEDURE TREATMENT: SURGICAL TREATMENT FOR HARDWARE REMOVAL PERFORMED FOR REMOVAL OF ALL HARDWARE 24 WEEKS POST-OP OUTCOME: RECOVERED/RESOLVED THIS REPORT IS FOR A LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 6 HOLES/69MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19281132 ↗
• InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AROUND (B)(6) 2020 THE PATIENT FELL FROM A SCAFFOLDING AND INJURED HIS RIGHT KNEE. THE CT SCAN REVEALED A COMMINUTED BICONDYLAR TIBIAL PLATEAU FRACTURE. AROUND (B)(6) 2020 THE PATIENT UNDERWENT RIGHT TIBIAL ORIF WITH MEDIAL POSTEROMEDIAL PLATING, MEDIAL AND LATERAL MENISCAL REPAIR AND A PROPHYLACTIC 4 COMPARTMENT FASCIOTOMY. THE SURGEON IMPLANTED A PROXIMAL ANTEROLATERAL SYNTHES TIBIAL PLATEAU LOCKING PLATE AND ONE 3.5 POSTEROMEDIAL TIBIAL T PLATE WITH ASSOCIATED SCREWS. THE SURGEON ALSO UTILIZED A SINGLE-USE DRILL BIT. FOLLOWING THE SURGERY OF (B)(6) 2020 THE PATIENT PERFORMED REHABILITATION AND THERAPY AS RECOMMENDED BY HIS MEDICAL PROVIDERS. HOWEVER, HE CONTINUED TO EXPERIENCE PAIN, DISCOMFORT, AND FUNCTIONAL LIMITATIONS IN HIS RIGHT KNEE. ALSO HE EXPERIENCED PROBLEMS WITH WOUND HEALING, INCLUDING INCREASED PAIN, SWELLING, AND DRAINAGE FROM THE INCISION SITE. AROUND (B)(6) 2020 THE PATIENT DIAGNOSED WITH SEPTIC ARTHRITIS. IT WAS DETERMINED THAT THE PATIENT WOULD UNDERGO ADDITIONAL SURGERY FOR HIS WOUND COMPLICATIONS, INCLUDING ARTHROSCOPIC IRRIGATION AND DEBRIDEMENT OF HIS MEDIAL AND LATERAL INCISIONS ALONG WITH THE REMOVAL OF ALL HIS HARDWARE AND THE INSTAL

  Patient problems: Discomfort; Impaired Healing; Loss of Range of Motion; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16753267 ↗
• InjuryNov 9, 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 A REMOVAL SURGERY OF PROXIMAL TIBIA HARDWARE DUE TO PAIN. THE PROCEDURE SUCCESSFULLY COMPLETED. THERE WAS NO KNOWN PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR ONE (1) LCP ONE-THIRD TUBULAR PL COLLAR 6 H/69. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12778753 ↗
• InjuryAug 25, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON REMOVED A BROKEN PLATE FROM THE PATIENT THAT WAS IMPLANTED IN A PREVIOUS SURGERY. THE SURGEON REPLACED THE PLATE WITH A THICKER PLATE. THE PROCEDURE OUTCOME AND PATIENT STATUS WERE NOT REPORTED. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 6 HOLES/69MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10450406 ↗
• InjuryDec 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO PAIN ON (B)(6) 2018. THE HARDWARE REMOVED WERE ONE (1) MALLEOLAR SCREW, FIVE (5) CORTEX SCREWS, TWO (2) CANCELLOUS SCREW AND ONE (1) TUBULAR PLATE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) LCP ONE THIRD TUBULAR PLATE. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 8195383 ↗
• InjuryOct 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HARDWARE REMOVAL PROCEDURE DUE TO PAIN ON (B)(6) 2018. HARDWARE REMOVED DURING THE PROCEDURE INVOLVES ONE (1) LOCKING COMPRESSION PLATE (LCP) ONE-THIRD TUBULAR PLATE WITH COLLAR, ONE (1) VARIABLE ANGLE LCP MEDIAL DISTAL TIBIA PLATE, SEVEN (7) CORTEX SCREWS, TWO (2) LOCKING SCREWS WITH STARDRIVE AND FIVE (5) VARIABLE ANGLE LOCKING SCREWS WITH T8 STARDRIVE. THE HARDWARE WAS IMPLANTED ON AN UNKNOWN DATE. DURING THE PROCEDURE THE FIVE (5) VARIABLE ANGLE LOCKING SCREWS BROKE. THE BROKEN SCREWS WERE FULLY REMOVED. THE BONE WAS HEALED AND NO ADDITIONAL HARDWARE WAS IMPLANTED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT ADDRESSES THE REVISION SURGERY DUE TO PAIN. ADDITIONAL PRODUCTS INVOLVED ARE ADDRESSED IN (B)(4). THE INTRAOPERATIVE ISSUE WITH THE BROKEN SCREWS IS ADDRESSED IN (B)(4). THIS REPORT IS FOR ONE (1) LCP ONE-THIRD TUBULAR PLATE WITH COLLAR THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7978334 ↗
• InjuryOct 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT AN ANKLE PROCEDURE IN (B)(6) 2018 TO IMPLANT TWO (2) LOCKING COMPRESSION PLATE (LCP) ONE THIRD TUBULAR PLATES, ONE (1) 2.7/3.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) ANTEROLATERAL DISTAL TIBIA PLATE, ONE (1) 2.7/3.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) MEDIAL DISTAL TIBIA PLATE, THIRTEEN (13) 3.5MM CORTEX SCREWS, TWELVE (12) 2.7MM VA LOCKING SCREWS, ONE (1) 7.0MM WASHER, ONE (1) 4.0MM CANNULATED SCREW, AND ONE (1) 4.0MM CANCELLOUS SCREW. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE ALL HARDWARE WAS REMOVED DUE TO INFECTION, INFLAMMATION, AND DELAYED HEALING. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT STATUS REPORTED AS OKAY. PATIENT IS REPORTED TO BE INCARCERATED AND NON-COMPLIANT. THIS REPORT IS FOR ONE (1) LCP ONE THIRD TUBULAR PLATE. THIS IS REPORT 2 OF 9 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7943939 ↗
• InjuryMar 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A RIGHT ANKLE HARDWARE REMOVAL WAS PERFORMED ON (B)(6) 2018 DUE TO PATIENT COMPLAINTS OF PAIN. DURING THE PROCEDURE A TIBIAL PLATE AND CORRESPONDING LOCKING SCREWS WERE REMOVED. THE EXACT AMOUNT OF SCREWS REMOVED IS UNKNOWN. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2017. THERE WAS NO DELAY OR FRAGMENTS GENERATED IN THE PATIENT. EVERYTHING WAS REPORTED AS EASILY REMOVED. THE PATIENT OUTCOME WAS REPORTED AS GOOD. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR A PLATE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7339514 ↗
• InjuryJan 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2017 DUE TO AN INFECTION. THE PATIENT¿S INITIAL INJURY WAS AN OPEN DISLOCATED ANKLE FRACTURE WITH A BROKEN FIBULA. ON (B)(6) 2016, PATIENT RECEIVED AN OPEN REDUCTION INTERNAL FIXATION (ORIF) AND WAS IMPLANTED WITH ONE (1) LOCKING COMPRESSION PLATE (LCP) ONE-THIRD TUBULAR PLATE AND SIX (6) UNKNOWN SCREWS, AS WELL AS AN IRRIGATION AND DEBRIDEMENT (I&D). THE PATIENT HAD A SLOW HEALING MEDIAL WOUND FROM THE INITIAL INJURY AND REFUSED SUBSEQUENT NECESSARY WOUND I&D'S, THEN PRESENTED WITH INFECTED WOUND AND COMPLETE EROSION OF THE TIBIAL TALAR JOINT. THE FIBULA HAD HEALED FROM THE INITIAL ORIF SURGERY ON (B)(6) 2016. FOR THE REVISION SURGERY, AN OSTEOTOMY WAS PERFORMED WITH A REMOVAL OF THE DISTAL THIRD FIBULA, AND DEBRIDEMENT WITH FUSION OF TIBIAL TALAR JOINT USING 6.5 MM CANNULATED SCREWS. HARDWARE REMAINED WITH REMOVED PORTION. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME REPORTED AS COMPLETE/OKAY. THIS IS REPORT 1 OF 2 FOR PC-(B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7160441 ↗
• InjuryMay 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD AN OPEN REDUCTION INTERNAL FIXATION REVISION SURGERY OF THE FIBULA. ALL EXISTING HARDWARE WAS REMOVED DUE TO FAILURE OF REDUCTION, WITH NO MALFUNCTION OF PRODUCT. THIS COULD OF POSSIBLY BEEN CAUSED BY THE PATIENT WEIGHT BEARING TOO SOON. PATIENT HAD NEW HARDWARE IMPLANTED AT TIME OF REVISION, A 5 HOLE RIGHT 2.7MM VARIABLE ANGLE(VA) LOCKING COMPRESSION PLATE (LCP) AND UNKNOWN NUMBER OF VA LOCKING SCREWS AND UNKNOWN NUMBER OF 3.5MM CORTICAL SCREWS. THE QUANTITY OF SCREWS TOTAL IS SIX (6). THERE WAS NO DELAY IN SURGERY. PATIENT'S OUTCOME IS UNKNOWN. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 6572787 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011335. One submission often covers many models, so check the product and lot details in each record.

• Z-2816-2020 · Jul 21, 2020 · Terminated
  DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, ol
• Z-1557-2013 · Feb 22, 2013 · Terminated
  Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011