MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. CPT 12/14 SIZE 3 COCR EXT; PROSTHESIS, HIP

Catalog Number	00811400310
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Periprosthetic fracture (4902)
Date of Event	11/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cocr head 32/ 0 'm' 12/14, item: 14320620, lot: 3056255.G2: foreign ¿ australia.H6: proposed component code: mechanical (g04) ¿ stem.The customer indicated that the product was discarded; therefore, it 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 6 years post-implantation after a bone scan identified a fracture at the distal tip of the femoral stem with associated pain.The stem and head were removed, and a revision femoral reconstruction was performed using the arcos system.Follow-ups to gather additional information are currently in process.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; h2; h3; h4; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: patient had an initial right tha and revised due to pain and peri prosthetic fracture.The operative notes from the procedure state there was a vancouver b fracture found around the stem of the medial calcar over the cortex of the femur.Stem was removed and replaced with an arcos system, and fracture stabilized with 3 cerclage wires with good fixation.No other complications noted.An x-ray image was provided, however was not further reviewed as the image of bone scan is of poor quality and postop image would not enhance the investigation.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.

• Brand Name: CPT 12/14 SIZE 3 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: 23843122
• Report Number: 0002648920-2025-00356
• Device Sequence Number: 9835364
• Product Code: JDI
• UDI-Device Identifier: 00889024145825
• UDI-Public: (01)00889024145825(17)300722(10)64774166
• 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: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: 00811400310
• Device Lot Number: 64774166
• 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: 11/27/2025
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2020
• 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; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Unknown