MAUDE Adverse Event Report: ZIMMER BIOMET, INC. A.L.P.S. CORTICAL LOCKING SCREW; PLATE, FIXATION, BONE

Catalog Number	856135014
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Codes	Skin Discoloration (2074); Aseptic loosening (4883)
Date of Event	07/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision of the alps elbow plate and screws approximately four (4) months post-implantation after it was discovered that two distal screws had come loose and backed out.The affected area also showed signs of pigmentation.Patient's rehabilitation protocol indicated the pain is subsiding, while they are also undergoing muscle strengthening exercising and range of motion exercises.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: item# 856135012; lot# 67088314, item# 851218000; lot# 66856145, item# 851235018; lot# 65899007, item# 851318601; lot# 66529483, item# 856135018; lot# 65685762, item# 856135018; lot# 65717503, item# 856135020; lot# 65781536, item# 856135020; lot# 66497435, item# 856135020; lot# 66772085.G2: foreign - event occurred in japan.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; d9; g1; g3; g6; h1; h2; h3; h6; h10.Visual examination of the returned products identified all of the screws show signs of use.The threads on the heads of the screws all show signs of damage.Some screws have damage to the threads on the body of the screw as well.Measured all the screws and the plate.The arms of the plate have been fractured and not all of the pieces were returned.Both screw holes at the distal end of the plate show signs of use and the threads are damaged.No measurements or function check were performed due to the damaged of the threads.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: comminuted fracture proximal ulnar metadiaphysis fixed with posterior plate and multiple screws shows dislodgment of distal screws and nonunion at visit 3.Bony sclerosis and periosteal reaction is noted at visit 3 which may be bony reaction to the unstable fracture.Operative notes were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing for part 856135012 and 856135014.A definitive root cause cannot be determined.Event was confirmed.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: A.L.P.S. CORTICAL LOCKING SCREW
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22862399
• Report Number: 0001825034-2025-02621
• Device Sequence Number: 18469864
• Product Code: HRS
• UDI-Device Identifier: 00887868351822
• UDI-Public: (01)00887868351822(17)341216(10)67041075
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 856135014
• Device Lot Number: 67041075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H11
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 50 YR
• Patient Sex: Female