MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. CPT 12/14 STEM SIZE 1 COCR; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Catalog Number	00811400100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Periprosthetic fracture (4902)
Date of Event	05/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).H10: g7 neutral e1 liner 36mm f.Item: 010000858.Lot: 6540483.G7 screw 6.5mm x 30mm.Item: 010000999.Lot: 6630191.G7 screw 6.5mm x 30mm.Item: 010000999.Lot: 6514781.G7 bonemaster ltd acet shl 54f.Item: 010000704.Lot: 6697800.Allen medullary cement plugs 1-20 mm diameter flange/10 mm diameter core store in cool dry place.Item: 00801102020.Lot: 64545191.G2: foreign ¿ australia.H6: suggested component code: mechanical (g04) - stem.The product was requested but was not returned by the hospital and will therefore not be sent 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 due to a periprosthetic fracture.It was confirmed that no further information could be provided.
Event or Problem Description
No additional information available for the reported event.
Additional Manufacturer Narrative
Final this follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; h2; h3; h4; h6 visual examination of the provided picture identified explanted devices, bio-debris present.Cannot be used to confirm the reported event.Device not returned, further analysis cannot be made.Review of the device history record identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: left total hip arthroplasty with acute periprosthetic femoral diaphysis fracture 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.

• Brand Name: CPT 12/14 STEM SIZE 1 COCR
• Common Device Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
• 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: 25596022
• Report Number: 0002648920-2026-00120
• Device Sequence Number: 5442939
• Product Code: JDI
• UDI-Device Identifier: 00889024145757
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted 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,Followup
• Report Date (Section B): 09/10/2026

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: 00811400100
• Device Lot Number: 64464788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2026
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 06/23/2026
• Supplement Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 163 LB