LCP 02.112.530Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982034670), received between Jun 26, 2018 and Sep 9, 2022 — classified as 5 injuries.

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

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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON WAS GOING TO REMOVE A MEDIAL DISTAL TIBIA PLATE BECAUSE OF WOUND DEHISCENCE AND PLATE EXPOSURE. THE HARDWARE WAS SUCCESSFULLY REMOVED. THIS REPORT INVOLVES ONE 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/14H/RIGHT/239MM. THIS IS REPORT 1 OF 8 FOR (B)(4).

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 15393775 ↗
• InjuryJan 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT AN EMERGENT INCISION AND DRAINAGE AND OPEN REDUCTION INTERNAL FIXATION (ORIF) RIGHT TIBIA DUE TO OSTEOMYELITIS AND INFECTION. ON AN UNKNOWN DATE THE PATIENT FELL WITH HER LEG WENT BEHIND HER, FRACTURING HER TIBIA. SHE ALSO HAD AN OPEN DEHISCENCE OF HER SURGICAL WOUND ON THE KNEE. DUE TO THE BEND OF THE KNEE AND THE SPLIT OF THE SKIN, SHE HAS BEEN BLEEDING AND HAS AN OPENING ON HER KNEE REPLACEMENT. ON (B)(6) 2019 THE PATIENT UNDERWENT AN OPEN TREATMENT OF TIBIAL SHAFT FRACTURE ON THE RIGHT SIDE WITH AN INTERNAL FIXATION WITH PLATE; A SECONDARY CLOSURE OF THE SURGICAL WOUND DEHISCENCE, AND AN EXTENSIVE AND COMPLICATED 8CM AND ARTHROTOMY KNEE WITH EXPLORATION AND DRAINAGE OF THE RIGHT KNEE, WHERE THE KNEE REPLACEMENT IS LOCATED.. THIS REPORT IS FOR ONE (1) 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/14H/RIGHT/239MM. THIS IS REPORT 1 OF 9 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9648256 ↗
• InjuryAug 23, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION OF OPEN REDUCTION INTERNAL FIXATION (ORIF) DISTAL TIBIA FRACTURE AND HARDWARE REMOVAL DUE TO MALREDUCTION AND NONUNION. THERE WAS NO BROKEN HARDWARE. THE FRACTURE WAS MALREDUCED. INITIALLY, THE FOLLOWING DEVICES; ONE (1) LOCKING COMPRESSION PLATE (LCP) BEND MEDIAL DISTAL TIBIA PLATE, THREE (3) 3.5 UNKNOWN CORTEX SCREWS AND SEVEN (7) UNKNOWN LOCKING SCREWS WERE IMPLANTED ON (B)(6) 2019. THE SURGEON VERBALIZED THAT THE PATIENT HAD BEEN TREATED SOMEWHERE ELSE AND THIS IS HOW THE FRACTURE HAD LOOKED POST-OP. HE STATED THAT IT WAS NOT A HARDWARE ISSUE. MOST PROXIMAL SCREWS IN SHAFT HAD BEEN PLACED VERY POSTERIOR IN THE SEGMENT AND IN SOME CASES TRANSCORTICAL. REMOVED EXISTING HARDWARE AND PLACED TIBIAL NAIL WITH BONE GRAFT. THERE WAS NO SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/14H/RIGHT/239MM. THIS REPORT IS 1 OF 10 FOR (B)(4).

  Patient problems: Bone Fracture(s); No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8927474 ↗
• InjuryDec 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE ANKLE. THE OPEN DISTAL TIBIA FRACTURE WAS PLATED WITH ONE (1) MEDIAL DISTAL TIBIA PLATE AND ONE (1) LOCKING COMPRESSION PLATE (LCP) PLATE. THE FIBULA WAS ALSO PLATED WITH A ONE-THIRD (1/3) TUBULAR PLATE. THE PATIENT HAD AN INFECTION DUE TO THE OPEN FRACTURE AND WAS MADE AWARE ON (B)(6) 2018. ACTION TAKEN WAS IRRIGATION AND DEBRIDEMENT. HARDWARE REMOVAL OCCURRED ON (B)(6) 2018. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR A 3.5MM LCP DISTAL TIBIA PLATE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8180194 ↗
• InjuryJun 26, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT REMOVAL OF ALL PROXIMAL RIGHT TIBIA AND DISTAL RIGHT TIBIA HARDWARE DUE TO THE LOCKING COMPRESSION PLATE (LCP) MEDIAL DISTAL PLATE WAS BROKEN THAT CAUSED THE NON-UNION OF THE RIGHT DISTAL TIBIA. ORIGINALLY, ONE (1) PARTIALLY THREADED CANNULATED SCREW, ELEVEN (11) SELF TAPPING SCREWS, SEVEN (7) CORTEX SCREWS, THREE (3) CONICAL SCREWS PARTIALLY THREADED, ONE (1) LOCKING LCP SMALL FRAGMENT PLATE, ONE (1) LOCKING COMPRESSION PLATE PROXIMAL TIBIAL, UNKNOWN NUMBER OF CONICAL SCREW FULLY THREADED, ONE (1) PROXIMAL TIBIAL PLATE LOW BEND, AND ONE (1) LOCKING COMPRESSION PLATE MEDIAL DISTAL WERE IMPLANTED FOR OPEN REDUCTION INTERNAL FIXATION (ORIF) OF PROXIMAL AND DISTAL TIBIA FRACTURE ON (B)(6) 2017. ALL BROKEN PIECES WERE SUCCESSFULLY REMOVED. THERE WAS NO SURGICAL DELAY REPORTED. THE PATIENT WAS STABLE AFTER THE PROCEDURE. AFTER THE REMOVAL OF ALL HARDWARE, IT WAS REPORTED THAT THE PROXIMAL FRACTURE WAS HEALED. CONCOMITANT DEVICE REPORTED: ZIMMER 3.5 PARTIALLY THREADED CANNULATED SCREW 70 MM (PART # 1147-070-35, LOT # UNKNOWN, QUANTITY 1), 3.5 MM LCP PROXIMAL TIBIAL PLATING SYSTEM (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), 70 MM

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7639165 ↗