MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZB 12/14 COCR HD 32MM X +0; PROSTHESIS, HIP

Catalog Number	802203202
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign: germany.H6: proposed component code: mechanical (g04) - head.Customer has indicated that the product is not available for evaluation has the device has been discarded.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during an initial total hip procedure, an incorrectly sized femoral head was implanted into the patient's joint.Subsequently, two (2) days post-implantation, the patient underwent revision surgery to replace the implant with a smaller sized head.Due diligence is in progress for this event; to date no additional information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; d4; g3; h2; h3; h4; h6; h11.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Investigation results concluded that the reported event was due to use error.The instructions for use for the device state 'improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components.Malalignment of the components or inaccurate implantation can lead to excessive wear and/or failure of the implant or procedure.' a summary of the investigation and proper technique was not sent to the complainant as the surgeon acknowledged the improper use and subsequently corrected it.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information at time of this report.

• Brand Name: ZB 12/14 COCR HD 32MM X +0
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23062444
• Report Number: 0001822565-2025-03439
• Device Sequence Number: 9849582
• Product Code: LPH
• UDI-Device Identifier: 00889024498839
• UDI-Public: (01)00889024498839(17)341125(10)3219832
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K183457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 802203202
• Device Lot Number: 3219832
• 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: 09/01/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female