MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. CPT 12/14 SIZE 4 COCR EXT; PROSTHESIS, HIP

Catalog Number	00811400410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Periprosthetic fracture (4902)
Date of Event	04/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign: australia.H6: component code: stem.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the patient underwent a revision procedure 2 years and 10 months post implantation due to a peri-prosthetic fracture.There is no further information available at the time of this report.
Event or Problem Description
No further event information is 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:.H6: component code: mechanical (g04) - stem product was not returned for evaluation; however, pictures were provided and reviewed.Visual examination of the provided pictures identified the explanted head, stem, and bearing covered in bio-debris.No further evaluation can be made.Review of the device history records identified no deviations or anomalies during manufacturing.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: periprosthetic fracture of the left femur.A definitive root cause cannot be determined.This complaint was confirmed based on the provided x-ray confirming the fracture.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: CPT 12/14 SIZE 4 COCR EXT
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22048308
• Report Number: 0002648920-2025-00139
• Device Sequence Number: 18461749
• Product Code: JDI
• UDI-Device Identifier: 00889024145863
• UDI-Public: (01)00889024145863(17)310220(10)64811394
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 08/11/2025

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: 00811400410
• Device Lot Number: 64811394
• 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: 04/28/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2021
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown