MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL HEAD 12/14 TAPER 28 MM DIAMETER +3.5 MM NECK LENGTH; PROSTHETIC, HIP

Catalog Number	802202803
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision procedure two and a half months post implantation due to dislocation.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).D10: 00500104728, item name: liner 28 mm i.D.For use with 47/48/49 mm o.D.Shells lot: unknown.G2: foreign: australia.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
It was reported that the patient underwent a revision procedure 2 and a half months post implantation due to recurrent dislocation.The patient's initial dislocation occurred after the primary surgery when no medical intervention was performed.There is no additional information available.
Event or Problem Description
Upon reassessment of the reported event, the device was determined to be not reportable as the head and liner did not dislocate.It was the shell dislocating from the patient's acetabulum.The initial report was forwarded in error and should be voided.
Additional Manufacturer Narrative
Upon reassessment of the reported event, the device was determined to be not reportable as the head and liner did not dislocate.It was the shell dislocating from the patient's acetabulum.The initial report was forwarded in error and should be voided.Sections updated: b4, b5, g3, g6, h2, h11.

• Brand Name: FEMORAL HEAD 12/14 TAPER 28 MM DIAMETER +3.5 MM NECK LENGTH
• Common Device Name: PROSTHETIC, 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: 21267382
• Report Number: 0001822565-2025-00200
• Device Sequence Number: 20984102
• Product Code: LPH
• UDI-Device Identifier: 00889024498792
• UDI-Public: (01)00889024498792(17)320706(10)3114619
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K183457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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,Followup
• Report Date (Section B): 05/06/2025

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: 802202803
• Device Lot Number: 3114619
• 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: 01/07/2025
• Supplement Date Received by Manufacturer: 02/02/2025; 04/23/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 02/12/2025; 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2022
• 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: PLEASE SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Unknown