MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN LINER; PROSTHESIS, HIPS

Catalog Number	UNKNOWN
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a revision surgery to replace the cup liner, the liner-removal screw contacted and displaced the cup-fixation screw, resulting in penetration through the screw hole.The penetrated screw was subsequently extracted without complication.Attempts have been made, and all additional information received has been included in this report.
Additional Manufacturer Narrative
(b)(4).D4: the primary unique device identification (udi) number is not applicable as the device's product number is unknown.Attempts have been made to gather all product identification information, and no further information has been provided.D10: item name# trilogy bone scr 6.5x15; item number # 00625006515; lot number # j7914134.G2: foreign: japan.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Complaint history review cannot be performed without product identification.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: fluoroscopic image of the hip confirms acetabular cup screw has penetrated through the screw hole, now residing deep and medial to the acetabular cup.A definitive root cause cannot be determined.It is not known whether the screw was hit upon removal of liner or if the screw had pushed through prior to removal.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.

• Brand Name: UNKNOWN LINER
• Common Device Name: PROSTHESIS, HIPS
• 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: 24739034
• Report Number: 0001822565-2026-00990
• Device Sequence Number: 14947670
• Product Code: LPH
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: NA
• 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): 03/31/2026

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: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• 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: 03/24/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown