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

Catalog Number	00811400010
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526); Aseptic loosening (4883)
Date of Event	06/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Proposed component code: mechanical (g04) ¿ stem.D10: cat# 110010242 lot# 66589774 g7 osseoti 3 hole shell 48mm c.Cat# 010000886 lot# 7028117 g7 10 deg e1 liner 32mm c.Cat# 010000999 lot# 7784803 g7 screw 6.5mm x 30mm.Cat# 00877503202 lot# 3165638 bioloxâ® delta, ceramic femoral head, m, 㸠32/0, taper 12/14.G2: foreign: australia.Visual examination of the provided pictures identified the explanted components covered in bio-debris.No further evaluation could be made from the provided pictures.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.Review of the available information indicates the device was assembled per technique, was released in a conforming state, and is functioning as expected per the documented design requirements.No device failure was identified.The complaint cannot 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
It was reported that the patient underwent an initial hip procedure.Subsequently, the patient was revised approximately 1 month later due to dislocation and instability.During the removal of the head, the stem came loose.All devices were revised and replaced.It was reported that no further information could be provided.

• 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: 22492704
• Report Number: 0002648920-2025-00181
• Device Sequence Number: 4106507
• Product Code: JDI
• UDI-Device Identifier: 00889024145740
• UDI-Public: (01)00889024145740(17)330424(10)65777128
• 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: 2025
• Device Explanted Year: 2025
• 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
• Report Date (Section B): 07/13/2025

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 Catalogue Number: 00811400010
• Device Lot Number: 65777128
• 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: 06/17/2025
• Initial Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2023
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 75 KG