MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZCA; PROSTHESIS, HIP

Catalog Number	00800564832
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately one month post-implantation, the patient underwent a hip revision due to unknown reasons to remove the prosthesis.A spacer and competitor stem and head were removed.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: unk corin head; unk corin stem.G2: foreign ¿ event occurred in australia.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.
Event or Problem Description
Upon receiving additional information of the reported event, it was determined to be not reportable as this product was not involved in the event.The initial report should be voided.
Additional Manufacturer Narrative
Upon receiving additional information of the reported event, it was determined to be not reportable as this product was not involved in the event.The initial report should be voided.

• Brand Name: ZCA
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24343514
• Report Number: 0001822565-2026-00502
• Device Sequence Number: 9674404
• Product Code: JDI
• UDI-Device Identifier: 00889024639010
• UDI-Public: (01)00889024639010(17)271207(10)65552158
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K191449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 02/26/2026

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: 00800564832
• Device Lot Number: 65552158
• 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: 01/19/2026
• Supplement Date Received by Manufacturer: 02/22/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 63 KG