MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRILOGY BONE SCR 6.5X20; PROSTHESIS, HIP

Catalog Number	00625006520
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: g7 pps ltd acet shell 52e; item: 010000663; lot: 7569901.G2: foreign ¿ brazil.The customer indicated that the product was discarded; therefore, it will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that the surgeon chose to remove the screw from the metal acetabular implant because he thought it did not give the final proper tightening, hindering the fixation of the polyethylene in the metal implant.Surgeon chose to leave only one screw in another hole of the acetabulum.No patient harm or impact reported.No additional information available for the reported event.

• Brand Name: TRILOGY BONE SCR 6.5X20
• 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: 24259095
• Report Number: 0001822565-2026-00412
• Device Sequence Number: 9600107
• Product Code: LPH
• UDI-Device Identifier: 00889024119802
• UDI-Public: (01)00889024119802(17)330211(10)J7435427
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K934765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/19/2026

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: 00625006520
• Device Lot Number: J7435427
• 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: 01/13/2026
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Age: 83 YR
• Patient Sex: Female