LCP 241.901Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10886982167620), received between Dec 11, 2013 and Nov 17, 2025 — classified as 23 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (8 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2025 IT WAS FOUND THAT ITEMS WERE WORN AND NEED TO BE REPLACED. RETENTION PINS WERE WARPED/BROKEN. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23574336 ↗
• MalfunctionNov 17, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2025 IT WAS FOUND THAT ITEMS WERE WORN AND NEED TO BE REPLACED. RETENTION PINS WERE WARPED/BROKEN. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23574294 ↗
• MalfunctionMay 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED, THAT ON UNKNOWN DATE. THE LOCKING HOLES ON THE PLATE WERE NOT ACCEPTING THE LOCKING SCREWS OR THREADED DRILL GUIDE. SCREWS WERE PLACED AND THEN PUT BACK IN. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: LOCKING (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 3.5 LCP PROXIMAL HUM PL-STD 3H SFT/90. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16974112 ↗
• InjuryOct 21, 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 PATIENT EXPERIENCED PAINFUL HARDWARE REQUIRING HARDWARE REMOVAL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 15650461 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A DISLOCATED 2 FRAGMENT PROXIMAL HUMERUS FRACTURED, AND THERE WAS INCISIONAL SEROMA (INFECTION). NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Joint Dislocation; Seroma

  MAUDE report 15649902 ↗
• InjuryOct 21, 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 PATIENT UNDERWENT SURGERY FOR DISLOCATED TWO FRAGMENT PROXIMAL HUMERUS FRACTURES. THE PATIENT EXPERIENCED POSTOPERATIVE PAIN REQUIRING REVISION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 15649760 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DISLOCATION OCCURRED IN TWO FRAGMENT PROXIMAL HUMERUS FRACTURES. THE PATIENT EXPERIENCED NON-UNION, AND SURGICAL INTERVENTION WAS REPORTED. THIS REPORT INVOLVES ONE 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15649690 ↗
• MalfunctionOct 21, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE LOCKING MECHANISM FAILED. A SECOND PLATE WAS USED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15649606 ↗
• MalfunctionOct 21, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS DIFFICULTY WITH REDUCTION/DISLOCATION. THIS REPORT INVOLVES ONE 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15649529 ↗
• InjuryOct 21, 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 PATIENT EXPERIENCED PAINFUL HARDWARE REQUIRING HARDWARE REMOVAL. THIS REPORT INVOLVES ONE 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 15649373 ↗
• InjuryOct 20, 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 PATIENT EXPERIENCED PAINFUL HARDWARE REQUIRING REMOVAL OF HARDWARE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 15643343 ↗
• InjuryOct 20, 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 PATIENT EXPERIENCED PAINFUL HARDWARE REQUIRING HARDWARE REMOVAL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 15643281 ↗
• InjuryOct 20, 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 PAINFUL HARDWARE REQUIRING HARDWARE REMOVAL. THIS REPORT IS FOR ONE 3.5 LCP PROXIMAL HUM PL-STD 3H SFT/90. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 15641431 ↗
• InjuryOct 20, 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 PATIENT EXPERIENCED PAINFUL HARDWARE REQUIRING HARDWARE REMOVAL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 15641053 ↗
• InjuryOct 20, 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 PATIENT EXPERIENCED PAIN REQUIRING HARDWARE REMOVAL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 15640357 ↗
• InjuryOct 20, 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 PATIENT EXPERIENCED PAIN REQUIRING HARDWARE REMOVAL. THIS REPORT INVOLVES ONE 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 15640192 ↗
• InjuryOct 20, 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 PATIENT EXPERIENCED PAIN AND LIMITED RANGE OF MOTION REQUIRING HARDWARE REMOVAL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 15640027 ↗
• InjuryOct 20, 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 PATIENT EXPERIENCED AN INFECTION AND LIMITED RANGE OF MOTION REQUIRING REMOVAL OF HARDWARE. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Loss of Range of Motion; Post Operative Wound Infection

  MAUDE report 15639856 ↗
• InjuryOct 20, 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 PATIENT EXPERIENCED PAINFUL HARDWARE REQUIRING REVISION AFTER REPAIR OF A DISLOCATED TWO FRAGMENT PROXIMAL HUMERUS FRACTURE. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 15639735 ↗
• InjuryOct 20, 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 PATIENT EXPERIENCED IMPLANT FAILURE. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15639600 ↗
• MalfunctionNov 16, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROXIMAL HUMERUS, THE SURGEON HAD DIFFICULTIES GETTING THE WIRE GUIDE SLEEVE FOR 3.7 CANNULATED SCREWS TO THREAD INTO THE PLATE. ULTIMATELY, HE SWITCHED TO USING A REGULAR LOCKING TO WE, A WIRE SLEEVE TO MEASURE THE SCREW AND PLACED IT SUCCESSFULLY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH FIVE(5) MINUTES SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 3.5 LCP PROXIMAL HUM PL-STD 3H SFT/90. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12820736 ↗
• MalfunctionApr 16, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING OPEN REDUCTION INTERNAL FIXATION PROXIMAL HUMERUS, PLATE WAS IN SITU WITH SEVERAL LOCKING SCREWS IN PLACE PROXIMALLY. WHILE ATTEMPTING TO REDUCE THE PLATE TO THE BONE, THE THREADED LOCKING TOWERS WOULD NOT STAY ENGAGED IN THE PLATE. PLATE WAS REMOVED, PERIARTICULAR PROXIMAL HUMERUS PLATE WAS USED INSTEAD. THE SURGERY WAS DELAYED FOR 10 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. CONCOMITANT DEVICES REPORTED: UNKNOWN LOCKING SCREWS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM. THIS REPORT IS 1 OF 4 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11679907 ↗
• InjuryJul 20, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REMOVAL OF THE PROXIMAL HUMERUS PLATE AND REVISION OF THE PROXIMAL HUMERUS FRACTURE WITH RIA BONE GRAFT. ORIGINALLY, THE PATIENT WAS IMPLANTED OF PLATE AND SCREWS ON (B)(6) 2020. THE REVISION PROCEDURE WAS PERFORMED DUE TO ONE LOCKING SCREW THAT BACKED OUT OF THE HEAD OF THE PLATE AND MALREDUCED THE FRACTURE. DURING THE REVISION PROCEDURE THE ORIGINAL IMPLANTS WERE REMOVED AND THE PATIENT WAS REVISED WITH PLATE AND BONE GRAFT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS WAS GOOD. CONCOMITANT DEVICE REPORTED: LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 10), CORTEX SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR 1 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 10299190 ↗
• MalfunctionDec 4, 2019Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON NOTICED A COIL OR SHAVING OF METAL THAT CAME OFF THE IMPLANTS WHEN REMOVING A 3.5MM LOCKING SCREW FROM A 3.5MM LOCKING COMPRESSION PLATE (LCP) PROXIMAL HUMERUS PLATE. THE METAL SHAVING WAS REMOVED AND THE SURGEON REPLACED THE SCREW WITH A SHORTER SCREW INTO THE HUMERUS. THE LOOSE SHAVING OF METAL WAS THEN DISPOSED. FRAGMENTS WERE GENERATED BUT EASILY REMOVED. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES: UNKNOWN 3.5MM LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9411698 ↗
• InjuryApr 8, 2019Adverse 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 REVISION OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT PROXIMAL HUMERUS DUE TO NONUNION. THE FOLLOWING HARDWARE WAS REMOVED: ONE (1) LOCKING COMPRESSION PLATE (LCP) PROXIMAL HUMERUS PLATE-STANDARD 3H HEAD SHAFT. ONE (1) CORTEX SCREW SELF-TAPPING 34MM. ONE (1) CORTEX SCREW SELF-TAPPING 30MM. TWO (2) LOCKING SCREW SELF-TAPPING WITH STARDRIVE RECESS 52MM. ONE (1) LOCKING SCREW SELF-TAPPING WITH STARDRIVE (TM) RECESS 40MM. ONE (1) LOCKING SCREW SELF-TAPPING WITH STARDRIVE RECESS 48MM. ONE (1) LOCKING SCREW SELF-TAPPING WITH STARDRIVE (TM) RECESS 38MM. ONE (1) LOCKING SCREW SELF-TAPPING WITH STARDRIVE (TM) RECESS 50MM. ONE (1) LOCKING SCREW SELF-TAPPING WITH STARDRIVE RECESS 46MM. ONE (1) LOCKING SCREW SELF-TAPPING WITH STARDRIVE (TM) RECESS 32MM. HARDWARE WAS ORIGINALLY IMPLANTED ON DECEMBER 23, 2017. ALL HARDWARE WAS REMOVED SUCCESSFULLY AND INTACT. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 3.5MM LCP® PROXIMAL HUMERUS PLATE. THIS IS REPORT 1 OF 10 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 8491087 ↗