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

Catalog Number	802202801
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Suggested component code: mechanical (g04) - head.D10: cat#: ep-200148, lot#: 66202329 act artic e1 hip brg 28x42mm.Cat#: 00833408402, lot#: 65430489 cement pressurizer medium.Cat#: p0463048, lot#: 0001799214 avan cmntd shell ss 48mm.Cat#: 42.19.40, lot#: 9999999999 countersunk cancell scr 6.5/40.Cat#: 42.19.30, lot#: 9999999999 countersunk cancell scr 6.5/30.Cat#: 01.00191.250, lot#: 3002257 b-s reinforcmnt ring new 50 rt.Cat#: 00811400110, lot#: 66348502 femoral stem 12/14 neck taper ext.Offset size 1 130 mm stem length.Cat#: 00801102024, lot#: 66352085 allen medullary cement plugs 1-24 mm diameter flange/12 mm diameter core store in cool dry place.G2: foreign: australia.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial hip procedure.Subsequently, the patient was revised approximately 1 year later due to dissociation.The head and bearing disassociated and were replaced.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: d4; g3; h2; h3; h4; h6.Visual examination of the provided picture identified the explanted implants but could not be used to confirm the complaint.Device not returned, further analysis cannot be made.Review of the device history records 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: a single undated image reviewed and not submitted to mmi due to the inability to correlate the image with the allegation.A definitive root cause cannot be determined.This 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.

• Brand Name: FEMORAL HEAD 12/14 TAPER 28 MM DIAMETER -3.5 NECK LENGTH
• 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: 21772899
• Report Number: 0001822565-2025-00891
• Device Sequence Number: 12782288
• Product Code: LPH
• UDI-Device Identifier: 00889024498778
• UDI-Public: (01)00889024498778(17)331115(10)3172598
• 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
• Report Date (Section B): 05/01/2025

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
• Device Catalogue Number: 802202801
• Device Lot Number: 3172598
• 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: 03/29/2025
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 81 KG