MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. TRILOGY BONE SCR 6.5X40; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	08/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision procedure 2 years post implantation due to infection and loosened cup.The head, liner and 5 screws were all explanted.Tissue samples were taken and the wound was closed.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).D10: 00620206420 item name shell porous with multi holes 64 mm lot# 62526380 00631006436 item name liner 10 degree elevated rim 3.5 mm offset 36 mm i.D.For use with 64 mm o.D.Shell lot # 63631271, 00-6250-065-30 item name trilogy bone scr 6.5x30 lot # j6911764, 00-6250-065-40 item name trilogy bone scr 6.5x40 lot # 64302116, 00-6250-065-20 item name trilogy bone scr 6.5x20 lot # 64246318, g2: foreign: australia.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02288, 0001822565-2023-02301, 0001822565-2023-02305, 0002648920 - 2023 - 00227, 0002648920 - 2023 - 00228.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted h3 other text : device location is unknown.
Event or Problem Description
There is no update to the prior event description provided.
Additional Manufacturer Narrative
Visual examination of the provided picture identified the explanted components on the surgical table covered in bio-debris.No further evaluation can be made from the provided picture.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined for the cup loosening.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards or better.Therefore, it is unlikely that the specified device caused any patient infection.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: TRILOGY BONE SCR 6.5X40
• Common Device Name: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17799149
• Report Number: 0002648920-2023-00226
• Device Sequence Number: 15168335
• Product Code: LPH
• UDI-Device Identifier: 00889024119840
• UDI-Public: (01)00889024119840(17)291031(10)64563149
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K934765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• 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): 11/17/2023

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 Model Number: N/A
• Device Catalogue Number: 00-6250-065-40
• Device Lot Number: 64563149
• 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: 09/06/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2019
• 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: Unknown
• 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: PLEASE SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male