MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRILOGY LONGEVITY LINER STANDARD 32 MM I.D.; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Joint Dislocation (2374)
Date of Event	10/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat#00877503203 lot# 2990793 biolox⮠delta, ceramic femoral head, l, 㸠32/+3.5, taper 12/14.Cat# 00620205022 lot# 64309077 shell porous with cluster holes 50 mm.Cat# 00786401220 lot# 64150702 femoral stem press-fit collarless 12/14 neck taper standard body extended neck offset size 12 128 mm stem length cementless.Cat# 00625006540 lot# 64424728 bone screw self-tapping 6.5 mm dia.40 mm length.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.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 the patient underwent an initial hip procedure.Subsequently, the patient was revised approximately 5 years later due to recurrent dislocations.During the revision, the head was dislocated.The head and liner were revised without complications.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: pain, dislocation, and scar tissue.A definitive root cause cannot be determined.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: TRILOGY LONGEVITY LINER STANDARD 32 MM I.D.
• 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: 20863213
• Report Number: 0001822565-2024-03841
• Device Sequence Number: 15663120
• Product Code: LPH
• UDI-Device Identifier: 00889024123755
• UDI-Public: (01)00889024123755(17)230731(10)64118548
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K990135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2025

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: 07/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00630505032
• Device Lot Number: 64118548
• 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: 11/26/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2018
• 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
• Patient Weight: 46 KG