MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. CPT 12/14 SIZE 0 COCR EXT; PROSTHESIS, HIP

Catalog Number	00811400010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Periprosthetic fracture (4902)
Date of Event	07/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: australia.H6: proposed component code: mechanical (g04) - stem.The customer has indicated that the product location is unknown and will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a hip revision approximately two years post-implantation due to a bone fracture.It was reported that no further information could be provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; h2; h3; h6.Visual examination of the provided picture identified an explanted stem and head covered in bio-debris.No further evaluation could be made with the provided picture.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: there is a right total hip arthroplasty in place with cemented femoral component.Small area of incomplete cement mantle coverage at the tip of the femoral stem.There is a regular linear lucency within the base of the greater trochanter at the top of the femoral implant that is favored to represent artifact.No discrete fracture is identified.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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 trends.
Event or Problem Description
No additional information available for the reported event.
Event or Problem Description
It was reported that the patient underwent a hip revision approximately two years post-implantation after the patient fell, resulting in a periprosthetic fracture.No additional information available for the reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a1; a2; a3; b5; g3; h2; h6.Once the investigation has been completed, a supplemental mdr will be submitted.

• Brand Name: CPT 12/14 SIZE 0 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: 22859790
• Report Number: 0002648920-2025-00219
• Device Sequence Number: 13064524
• Product Code: JDI
• UDI-Device Identifier: 00889024145740
• UDI-Public: (01)00889024145740(17)330723(10)65960374
• 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: 2023
• 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,Followup
• Report Date (Section B): 10/30/2025

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: 00811400010
• Device Lot Number: 65960374
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: 09/21/2025; 10/30/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 10/15/2025; 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2023
• 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: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female