MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRILOGY ACETABULAR SYSTEM LINER; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Dislocation (2374); Insufficient Information (4580)
Date of Event	04/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (b)(4).
Event or Problem Description
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (b)(4).
Additional Manufacturer Narrative
(b)(4).D10: cat# 00877503603 lot# 2897044 bioloxâ® delta, ceramic femoral head, l, 㸠36/+3.5, taper 12/14 cat# 00625006530 lot# 63696911 bone scr 6.5x30 self-tap cat# 32833401002 lot# 63667127 femoral pressurizer seal small natural cat# 00801102020 lot# 63777096 allen medullary cement plugs 1-20 mm diameter flange/10 mm diameter core 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 approximately six years post-implantation, the patient underwent a hip revision due to unknown reasons.The liner was revised.It is unknown if other components were revised.Attempts have been made and no further information has been provided.
Event or Problem Description
It was reported that approximately six years post-implantation, the patient underwent a hip revision due to dislocation.The liner and head were revised.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: g3; h2; h4.The following sections were corrected: b1; b5; h6 clinical and device code.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: TRILOGY ACETABULAR SYSTEM LINER
• 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: 20070420
• Report Number: 0001822565-2024-02746
• Device Sequence Number: 18266715
• Product Code: LPH
• UDI-Device Identifier: 00889024123762
• UDI-Public: (01)00889024123762(17)220331(10)63613766
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K002960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• 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): 09/26/2024

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: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00630505036
• Device Lot Number: 63613766
• 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: 08/05/2024
• Supplement Date Received by Manufacturer: 08/27/2024; 09/25/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 09/16/2024; 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2017
• 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: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female