LCP 241.351Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886982166852), received between Oct 13, 2017 and Oct 18, 2022 — classified as 14 injuries, 1 malfunction.

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

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON SEPTEMBER 27, 2022, THE SURGEON PERFORMED A REMOVAL OF HARDWARE DUE TO PAIN AND IRRITATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 5 HOLES/57MM. THIS IS REPORT 14 OF 14 FOR (B)(4).

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 15628829 ↗
• MalfunctionOct 29, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, THE SURGEON COMMENTED THAT THE DISTAL FIBULA PLATE WAS TOO BULKY AND DECIDED TO REMOVE IT IN EXCHANGE FOR A 1/3 TUBULAR PLATE ON THE FIBULA. WHILE USING A 1/3 TUBULAR ON THE MEDIAL SIDE OF THE TIBIA, THE SURGEON COULD NOT GET THE LOCKING MECHANISM TO FUNCTION, HOWEVER, IT WAS POSSIBLE THAT THE LOCKING HOLE WAS DEFORMED BY PUTTING A PREVIOUS NON-LOCKING SCREW. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR (1) LCP ONE-THIRD TUBULAR PL COLLAR 5 H/57. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12719732 ↗
• InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, THERE WAS A REMOVAL OF LCP ONE-THIRD TUBULAR PLATE 3.5 AND 2.7 MM LCP PLATE IN ANKLE. PATIENT WAS INFECTED AND NON COMPLIANT. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR ONE (1) LCP ONE-THIRD TUBULAR PL COLLAR 5 H/57. THIS REPORT IS 4 OF 5 FOR (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 12013353 ↗
• InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, THERE WAS A REMOVAL OF LCP ONE-THIRD TUBULAR PLATE 3.5 AND 2.7 MM LCP PLATE IN ANKLE. PATIENT WAS INFECTED AND NON COMPLIANT. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR ONE (1) LCP ONE-THIRD TUBULAR PL COLLAR 5 H/57. THIS REPORT IS 3 OF 5 FOR (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 12013266 ↗
• InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, THERE WAS A REMOVAL OF LCP ONE-THIRD TUBULAR PLATE 3.5 AND 2.7 MM LCP PLATE IN ANKLE. PATIENT WAS INFECTED AND NON COMPLIANT. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR ONE (1) LCP ONE-THIRD TUBULAR PL COLLAR 5 H/57. THIS REPORT IS 1 OF 5 FOR (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 12013261 ↗
• InjuryJun 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REVISION OF A MIDSHAFT NONUNION IN THE LEFT HUMERUS AND RIGHT TIBIA. IN PATIENT'S HUMERUS, DYNAMIC COMPRESSION PLATES WITH LIMITED BONE CONTACT (LC-DCP) AND NARROW DYNAMIC COMPRESSION PLATES WITH LIMITED BONE CONTACT (LC-DCP) WERE REMOVED, ALONG WITH TWELVE CORTEX SCREWS. PATIENT WAS REVISED TO A NEW LCDCP LARGE FRAGMENT PLATE AND BONE GRAFT HARVESTED FROM THE PATIENT¿S TIBIA. IN PATIENT'S TIBIA, LOCKING COMPRESSION PLATE (LCP) AND LOCKING COMPRESSION PLATE (LCP) TUBULAR PLATE WERE REMOVED, ALONG WITH TWENTY-ONE CORTEX SCREWS. A RIA WAS USED IN THE TIBIA TO RETRIEVE BONE GRAFT. SURGEON CORRECTED THE DEFORMITY, AND PATIENT¿S TIBIA WAS REVISED WITH A TIBIAL NAIL ADVANCED, AND PLACEMENT OF NEW SCREWS IN REMAINING TWO PLATES. FRAGMENT WERE GENERATED AND WAS REMOVED EASILY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH FIVE MINUTES SURGICAL DELAY. THIS COMPLAINT INVOLVES FORTY-TWO (42) DEVICES. THIS REPORT IS FOR ONE LCP ONE-THIRD TUBULAR PL COLLAR 5 H/57 THIS REPORT IS FOR 13 OF THE 42 DEVICES

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11991917 ↗
• InjuryJul 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A HARDWARE REMOVAL OF THE LOCKING COMPRESSION PLATING SYSTEM (LCP) OF THE DISTAL TIBIA DUE TO INFECTION. INITIALLY, THE PATIENT WAS IMPLANTED WITH AN LCP SYSTEM ON (B)(6) 2018. THE SURGEON COMMENTED THAT THE PATIENT HAD DEVELOPED SKIN ULCERS EARLY ON, WHICH CAUSED INFECTION FROM WEARING HIS POST-OP BOOT TOO TIGHT. THE HARDWARE WAS REMOVED, AND THE REMOVAL SURGERY WAS COMPLETED. THE PATIENT IS OK. CONCOMITANT DEVICES REPORTED: 3.5MM LCP DISTAL TIBIA T-PLATE 3 HOLE/64MM (PART NUMBER 02.112.203, LOT UNKNOWN, QUANTITY 1), 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/6 HOLES/LEFT (PART NUMBER 02.118.205, LOT UNKNOWN, QUANTITY 1), SCREWS: LOCKING (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 11) SCREWS: CORTEX (PART NUMBER UNKNOWN, LOT UNKNOWN QUANTITY 9). THIS PRODUCT COMPLAINT, (B)(4), IS RELATED TO (B)(4). (B)(4) CAPTURES THE 10 OF 23 DEVICES, (B)(4) CAPTURES THE 10 OF 23 DEVICES, AND (B)(4) CAPTURES THE 3 OF 23 DEVICES. THIS REPORT INVOLVES ONE (1) LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 5 HOLES/57MM. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Ulcer; Unspecified Infection

  MAUDE report 10233169 ↗
• InjuryOct 9, 2019Break; Break

  FURTHER IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT VISITED A CLINIC FOR A FOLLOW-UP STATUS POST HIS REVISION ORIF OF THE PROXIMAL ULNA FRACTURE. HE IS DOING WELL. HE HAS MINIMAL COMPLAINTS OF PAIN. THE PATIENT HAS NO COMPLAINTS AND HAS FULL RANGE OF MOTION OF HIS LEFT ARM. X-RAY SHOWS COMPLETE UNION OF THE LEFT ULNA WITH CALLUS FORMATION AND HARDWARE INTACT. WELL-HEALED SCARS, PALPABLE CALLUS NON TENDER LEFT FOREARM.

  Patient problems: No Code Available

  MAUDE report 9172442 ↗
• InjuryFeb 22, 2019Adverse 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 FROM ANKLE DUE TO INFECTED NONUNION ON (B)(6) 2019. HARDWARE REMOVED WAS ONE (1) LOCKING COMPRESSION PLATE ONE -THIRD TUBULAR PLATE WITH COLLAR 5 HOLES/ 57MM, ONE (1) LOCKING COMPRESSION PLATE ONE -THIRD TUBULAR PLATE WITH COLLAR 8 HOLES/ 93MM, ONE (1) 2.7MM VARIABLE ANGLE - LOCKING COMPRESSION PLATE, ONE (1) 2.4/2.7MM VARIABLE ANGLE - LOCKING COMPRESSION PLATE T-FUSION, ONE (1) 2.7/3.5MM VARIABLE ANGLE - LOCKING COMPRESSION PLATE ANTEROLATERAL, TWO (2) UNKNOWN 2.7 CORTEX SCREWS, FIFTEEN (15) UNKNOWN 2.7MM VA LOCKING SCREWS, TWO (2) UNKNOWN 3.5MM LOCKING SCREWS AND ELEVEN (11) UNKNOWN 3.5MM CORTEX SCREWS. THE SITE WAS I&D AND ANTIBIOTIC CEMENT WAS PLACED IN BONE VOID AND THEN A MAXFRAME WAS PLACED. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS IS STABLE. ORIGINAL IMPLANT DATE IS REPORTED AS (B)(6) 2018. THIS REPORT IS FOR ONE (1) LOCKING COMPRESSION PLATE ONE -THIRD TUBULAR PLATE WITH COLLAR 5 HOLES/ 57MM. THIS IS REPORT 1 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 8362669 ↗
• 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 1 OF 9 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7943891 ↗
• InjuryMar 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT ORIGINAL SURGERY FOR TREATMENT OF A PROXIMAL TIBIAL FRACTURE ON (B)(6) 2016. POST-OPERATIVELY, PATIENT COMPLAINED THAT WHEN THE WEATHER CHANGES,HER FEET WOULD FEEL VERY COLD ABOUT THE IMPLANT SITE. ON (B)(6) 2018, PATIENT UNDERWENT HARDWARE REMOVAL SURGERY AND THE FOLLOWING DEVICES FOURTEEN (14) WERE REMOVED - ONE (1) PROXIMAL TIBIA PLATE, ONE (1) LOCKING COMPRESSION TUBULAR PLATE, ONE (1) 8 HOLES LOCKING COMPRESSION PLATE, TWO (2) 4.5 MM CORTEX SCREWS, FOUR (4) 5.0 MM LOCKING SCREWS AND FIVE (5) 3.5 MM CORTEX SCREWS .THERE WAS NO REPORTED MALFUNCTIONS ASSOCIATED WITH ANY OF THE DEVICES. ALL OF THE DEVICES WERE REMOVED EASILY AND THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. THE HARDWARE REMOVAL SURGERY WAS COMPLETED WITHOUT ANY REPORTED DELAY. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7313827 ↗
• InjuryDec 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HARDWARE REMOVAL OF AN OLECRANON PLATE CONSTRUCT ON (B)(6) 2017 DUE TO INFECTION. THE PATIENT HAD PRESENTED TO OPERATING ROOM (OR) ON (B)(6) 2017 FOR A GRADE 2 OPEN COMMINUTED OLECRANON FRACTURE AND A MEDIAL EPICONDYLE AVULSION. ALL REMOVED HARDWARE WAS INTACT. THE DISTAL HUMERUS HARDWARE REMAINS IMPLANTED. THE SURGEON STATED THAT THE INFECTION WAS MOST LIKELY DUE TO AN OPEN WOUND AND PATIENT HYGIENE ISSUES. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADDITIONAL MEDICAL INTERVENTION. PATIENT WAS LISTED AS STABLE POST-OPERATIVELY. (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7127980 ↗
• InjuryDec 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT HARDWARE REMOVAL SURGERY ON (B)(6), 2017 DUE TO A REFRACTURED ANKLE. THE PATIENT ORIGINALLY UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE LEFT ANKLE AND WAS IMPLANTED WITH A CANCELLOUS BONE SCREW, 3 CORTEX SCREWS, AND A TUBULAR PLATE ON AN UNKNOWN DATE IN (B)(6) 2017. HOWEVER, SOMETIME LAST WEEK, THE PATIENT TRIPPED ON A CURB AND REFRACTURED HIS LEFT ANKLE. THE RESULTS OF THE HARDWARE REMOVAL SURGERY WERE SUCCESSFUL, THE PATIENT WAS REPORTED TO BE IN EXCELLENT CONDITION. ALL THE ORIGINALLY IMPLANTED HARDWARE WAS REPLACED WITH NEW IMPLANTS. THERE WAS NO REPORTED SURGICAL DELAY. ALL AVAILABLE INFORMATION WAS RECEIVED FROM THE SALES CONSULTANT. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s); Impaired Healing

  MAUDE report 7110054 ↗
• InjuryOct 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017 DURING A SECOND REVISION SURGERY TO TREAT BICONDYLAR PROXIMAL TIBIA FRACTURE OF LEFT LEG, PATIENT UNDERWENT HARDWARE REMOVAL. THE FRACTURE DID NOT HEAL AS EXPECTED AND THE PATIENT PRESENTED NON-UNION. DUE TO THIS REASON, THIS SECOND REVISION SURGERY WAS PERFORMED. A TOTAL OF THREE (3) PLATES AND EIGHTEEN (18) SCREWS WERE REMOVED. ONE (1) PLATE WAS RETAINED WITHIN THE PATIENT. ALL THE IMPLANTS WERE REMOVED WITHOUT ANY DIFFICULTY AND WERE FOUND BE INTACT. THERE WAS NO REPORTED PRODUCT PROBLEM. THIS 2ND REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THE PATIENT WAS IMPLANTED WITH A COMPETITOR¿S DEVICE (TOTAL KNEE, STRYKER) AND IS REPORTED TO BE IN STABLE CONDITION. THIS COMPLAINT IS FOR TWENTY ONE (22) DEVICES. THIS REPORT IS 3 OF 22 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 6947992 ↗
• InjuryOct 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017 DURING A SECOND REVISION SURGERY TO TREAT BICONDYLAR PROXIMAL TIBIA FRACTURE OF LEFT LEG, PATIENT UNDERWENT HARDWARE REMOVAL. THE FRACTURE DID NOT HEAL AS EXPECTED AND THE PATIENT PRESENTED NON-UNION. DUE TO THIS REASON, THIS SECOND REVISION SURGERY WAS PERFORMED. A TOTAL OF THREE (3) PLATES AND EIGHTEEN (18) SCREWS WERE REMOVED. ONE (1) PLATE WAS RETAINED WITHIN THE PATIENT. ALL THE IMPLANTS WERE REMOVED WITHOUT ANY DIFFICULTY AND WERE FOUND BE INTACT. THERE WAS NO REPORTED PRODUCT PROBLEM. THIS 2ND REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THE PATIENT WAS IMPLANTED WITH A COMPETITOR¿S DEVICE (TOTAL KNEE, STRYKER) AND IS REPORTED TO BE IN STABLE CONDITION. THIS COMPLAINT IS FOR TWENTY ONE (22) DEVICES. THIS REPORT IS 2 OF 22 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 6947831 ↗

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