MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 28MM I.D. 44MM O.D. SIZE F BEARING; PROSTHESIS, HIP

Catalog Number	110031012
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: cat# 802202801, lot# 3248310, femoral head 12/14 taper 28 mm diameter -3.5 neck length.G2: foreign: belgium.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during the procedure, it was identified that the bearing was related to zfa-2025-00219 as a nonstandard device.The head was already inserted into the bearing, and it was too late to remove it.Both products are being returned.The surgery was completed with another implant and there was no delay or impact to the patient.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: d4; d9; g3; h2; h3; h4; h6.Visual examination of the returned product identified there are scratches and indentation marks in multiple areas around the o.D.Of the liner.No other damage was noted during visual evaluation.Per these p.I.Measurements the returned device dimensionally measures as item # 110031013.Review of the device history records identified no deviations or anomalies during manufacturing.It was later identified a commingle occurred during manufacturing.Medical records were not provided.The root cause of the reported issue is attributed to a manufacturing deficiency.Multiple complaints were identified that involved a 46mm bearing and a 44mm bearing that did not measure to the size listed on the box they were packaged in.They are related due to the fact that both lots are manufactured at warsaw west, of the same part family, and manufactured at the same time.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 information at the time of this report.

• Brand Name: 28MM I.D. 44MM O.D. SIZE F BEARING
• 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: 23920560
• Report Number: 0001822565-2025-04895
• Device Sequence Number: 15659695
• Product Code: LPH
• UDI-Device Identifier: 00889024572706
• UDI-Public: (01)00889024572706(17)300406(10)67160447
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K190656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 110031012
• Device Lot Number: 67160447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: ZFA-2025-00219
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Patient Sex: Unknown