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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	06/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D6a: implant date ¿ 2019.G2: foreign ¿ italy.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that approximately five years post-implantation, the patient underwent a hip revision due to significant wear of the liner that is not normal for the time elapsed since implantation.During the procedure, the liner was broken and mobilized, which led to the head rubbing on the metal shell causing wear.The cup was revised and had damage to the outer ring with a piece broken off.Surgeon noted slight accentuated anteversion.The acetabular component was 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: a3; b5; g3; h2; h6; h10.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that approximately five years post-implantation, the patient underwent a hip revision due to groin pain and significant wear of the liner that is not normal for the time elapsed since implantation.During the procedure, the liner was broken and mobilized, which led to the head rubbing on the metal shell causing wear.The cup was revised and had damage to the outer ring with a piece broken off.Surgeon noted slight accentuated anteversion.The acetabular component was revised.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: d9; g3; h2, h3; h6 visual examination of the returned liner confirmed the device had fractured.Three fragmented pieces were returned and it could not be confirmed if all pieces were returned due to damage.Bio debris was found on the liner.Nicks, gouges, and scratches were found on all areas of the device.Inner and outer spherical surface showed significant wear damage.Polar boss was deformed or worn / broken on the liner.No other damage was noted.Fracture analysis concluded that the timeline of the implant fracture(s) cannot be determined, but the liner rim fracture was possibly caused by overloading, with further overloading exacerbated by misalignments after the initial fracture leading to further rim and boss fractures, resulting in the liner completely disassociating from the shell and subsequent ceramic-on-metal articulation.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.The complaint is confirmed based on the returned product evaluation.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 ACETABULAR SYSTEM SHELL
• 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: 19559681
• Report Number: 0001822565-2024-02027
• Device Sequence Number: 20046366
• Product Code: LPH
• UDI-Device Identifier: 00889024118126
• UDI-Public: (01)00889024118126(17)260630(10)64045168
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K934765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/26/2024

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 Model Number: N/A
• Device Catalogue Number: 00620005422
• Device Lot Number: 64045168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/07/2024
• Supplement Date Received by Manufacturer: 07/01/2024; 11/21/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/03/2024; 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2018
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male