MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. CPT 12/14 STEM SIZE 1 COCR; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a hip arthroplasty and was implanted with zimmer biomet products.Subsequently, the patient was revised two (2) months post implantation due to dislocation of the undersized stem.Stem, bearing, and liner were explanted.
Additional Manufacturer Narrative
(b)(4).D10: 110031012 28mm i.D.44mm o.D.Size f bearing 66603521.110024464, g7 dual mobility liner 44mm f, 66411978.G2: foreign: australia.Proposed component code: mechanical (g04)- stem.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4;g3;h2;h3;h6;h10.H6: component code: mechanical (g04) - stem.Product not returned; however, a picture was provided and reviewed.Visual examination of the provided picture identified the explanted stem, bearing, and head, covered in bio-debris.The head and bearing were still assembled.No further evaluation can be made.Review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right total hip arthroplasty with superior and likely posterior dislocation of the right femoral head.Possible loosening of the femoral component.Possible undersized right femoral head.A definitive root cause cannot be determined.The size of the implants are the surgeon's discretion based on the patient anatomy.This complaint cannot be confirmed.The report of the undersized stem cannot be confirmed.The dislocation can be confirmed.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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: CPT 12/14 STEM SIZE 1 COCR
• Common Device Name: PROSTHESIS, HIPS
• 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: 22168788
• Report Number: 0002648920-2025-00157
• Device Sequence Number: 13063649
• Product Code: JDI
• UDI-Device Identifier: 00889024145757
• UDI-Public: (01)00889024145757(17)340402(10)66650980
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K191735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 07/22/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00811400100
• Device Lot Number: 66650980
• 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: 05/15/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Unknown
• Patient Weight: 66 KG