LCP 242.531SRecalls & reported problems
Synthes GmbH · 2.0MM LCP DISTAL ULNA PLATE 7 HOLE-STERILE · Class 2 · Implant
All models of LCP (367)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982168757), received between May 27, 2025 and May 28, 2025 — classified as 4 injuries, 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Break1
- Migration1
Patient problems
- Pain3
- Loss of Range of Motion2
- Nonunion/Delayed-union Bone Fracture2
- Insufficient Information1
- Malunion of Bone1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 28, 2025Break; Break
IT WAS REPORTED THAT THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 7 PATIENTS THAT WERE IMPLANTED WITH DEPUY SYNTHES (DPS) LCP 2.0 DISTAL ULNA PLATE. IMPLANTATION WAS BETWEEN 2008 AND 2023 AT CLEVELAND CLINIC FOUNDATION (CCF). PATIENT NUMBER 5. PATIENT IS A 68-YEAR-OLD FEMALE WHO UNDERWENT DISTAL ULNA FRACTURE FIXATION. REASON FOR IMPLANTATION WAS SUB CAPITAL FRACTURE (EXTRA-ARTICULAR). POST OP COMPLICATION INCLUDED ULNAR PLATE FAILURE - BUT MAINTAINED GOOD POSITION. IMPLANT(S) INVOLVED: 242.531S. COMBINATION SCREWS X5 02.111.531. COMBINATION SCREW X9.
Patient problems: Insufficient Information
MAUDE report 22100623 ↗InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 7 PATIENTS THAT WERE IMPLANTED WITH DEPUY SYNTHES (DPS) LCP 2.0 DISTAL ULNA PLATE. IMPLANTATION WAS BETWEEN 2008 AND 2023 AT (B)(6) CLINIC. PATIENT NUMBER (B)(6). PATIENT IS A 30-YEAR-OLD FEMALE WHO UNDERWENT DISTAL ULNA FRACTURE FIXATION. REASON FOR IMPLANTATION WAS SUB CAPITAL FRACTURE (EXTRA-ARTICULAR). POST OP COMPLICATION INCLUDED PAINFUL ULNAR HARDWARE, LEFT WRIST, ROTATIONAL DEFICIT, LEFT FOREARM AND MALUNION, LEFT DISTAL ULNA. IMPLANT(S) INVOLVED: 242.531S. COMBINATION SCREWS X4, 02.111.531. COMBINATION SCREW X7.
Patient problems: Loss of Range of Motion; Malunion of Bone; Pain
MAUDE report 22100444 ↗InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 7 PATIENTS THAT WERE IMPLANTED WITH DEPUY SYNTHES (DPS) LCP 2.0 DISTAL ULNA PLATE. IMPLANTATION WAS BETWEEN 2008 AND 2023 AT CLEVELAND CLINIC FOUNDATION (CCF). PATIENT NUMBER 3. PATIENT UNDERWENT DISTAL ULNA FRACTURE FIXATION. REASON FOR IMPLANTATION WAS CAPITAL FRACTURE (INTRA-ARTICULAR). POST OP COMPLICATION INCLUDED LEFT RADIUS NONUNION WITH FAILED HARDWARE. INTERVENTIONS WERE REPAIR OF LEFT RADIUS NONUNION WITH ALLOGRAFT AND REVISION OPEN REDUCTION INTERNAL FIXATION AND DEEP IMPLANT REMOVAL, LEFT RADIUS.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 22095909 ↗InjuryMay 27, 2025Migration; Migration
THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 7 PATIENTS THAT WERE IMPLANTED WITH DEPUY SYNTHES (DPS) LCP 2.0 DISTAL ULNA PLATE. IMPLANTATION WAS BETWEEN 2008 AND 2023 AT CLEVELAND CLINIC FOUNDATION (CCF). PATIENT NUMBER 1. PATIENT IS A 76-YEAR-OLD FEMALE WHO UNDERWENT DISTAL ULNA FRACTURE FIXATION. REASON FOR IMPLANTATION WAS SUBCAPITAL FRACTURE (EXTRA-ARTICULAR). POST OP COMPLICATION INCLUDED PAINFUL HARDWARE, LEFT ULNA -- SOME RESTRICTION OF ROTATION AND SUSPICION THAT ONE OF THESE SCREWS IN THE ULNAR PLATE IS IMPINGING ON THE RADIUS, TENDERNESS OVER LENGTH OF THE PLATE. IMPLANT(S) INVOLVED: 242.531S. COMBINATION SCREWS X7 02.111.641. COMBINATION SCREWS X8.
Patient problems: Loss of Range of Motion; Pain
MAUDE report 22090132 ↗InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 7 PATIENTS THAT WERE IMPLANTED WITH DEPUY SYNTHES (DPS) LCP 2.0 DISTAL ULNA PLATE. IMPLANTATION WAS BETWEEN 2008 AND 2023 AT (B)(6) CLINIC FOUNDATION (CCF). PATIENT NUMBER (B)(6). PATIENT IS AN 80-YEAR-OLD FEMALE WHO UNDERWENT DISTAL ULNA FRACTURE FIXATION. REASON FOR IMPLANTATION WAS SUBCAPITAL FRACTURE (EXTRA-ARTICULAR). POST OP COMPLICATION INCLUDED PAIN, LEFT WRIST, PAINFUL ORTHOPEDIC HARDWARE, LEFT WRIST AND NONUNION DISTAL ULNA FRACTURE. INTERVENTION WAS REMOVAL OF ULNA HARDWARE FROM LEFT WRIST WITH DISTAL ULNA RESECTION.
Patient problems: Nonunion/Delayed-union Bone Fracture; Pain
MAUDE report 22089967 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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