MAUDE Adverse Event Report: Zimmer Biomet, Inc. A.L.P.S.CORTICAL LOCKING SCREW; Plate, Fixation, Bone

Catalog Number	856135065
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Fistula (1862); Hypersensitivity/Allergic reaction (1907); Rash (2033); Discomfort (2330); Medical device site infection (4845)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following an initial fixation procedure on the tibia for a tibial plateau fracture, redness, a rash, and a fistula were observed at the surgical site and the patient reported discomfort.An infection was reported, and a metal allergy was suspected.At five months following implantation, the construct was removed and an artificial bone block was placed.Following the construct explantation, the fistula closed and the clinical course was reported to be without problems.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event.Associated reports are available for the applicable concomitant products in the d10 narrative below.D10: concomitant medical products, part (lot): - 836235805 (sbm192947), - 851235038 (222140), - 856135030 (67340500), - 856135034 (67196851), - 856135054 (664520), - 856135054 (160650), - 856135056 (046580), - 856135060 (66884146), - 856135065 (66902146), - 856135065 (67625312), - 856135065 (67625312), - 856135065 (67625312).G2: foreign - event occurred in japan.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

• 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 ; +1(574)526-0384
• MDR Report Key: 50393124
• Report Number: 0001825034-2026-02486
• Device Sequence Number: 21172854
• Product Code: HRS
• UDI-Device Identifier: 00887868352065
• UDI-Public: (01)00887868352065(17)341206(10)66952351
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 856135065
• Device Lot Number: 66952351
• Was Device Available for Evaluation?: No
• 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: Not provided
• Initial Report FDA Received Date: 08/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2024
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown