MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRABECULAR METAL ACET SHELL 54MM CLUSTER; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 00630505036 item name liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells lot / software release # 62757083 00-8775-036-01 item name biolox delta hd 12/14 36x3.5 lot # 2798737.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.
Event or Problem Description
It was reported that the patient underwent a revision procedure 7 years and 8 months post implantation due to the patient's hip squeaking.Surgeon believes the wear on the liner and possible placement issues caused the squeaking in the patient and therefore damaged the cup and head.There is no additional information available at the time of this report.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4;g3;h2;h3;h6;h10.The following section was corrected: g4.No product was returned; however, pictures were provided and reviewed.A visual examination of the provided pictures identified that the explanted head, liner and shell were covered in biodebris.The head was observed to have outer surface scratch marks.The liner was observed with the rim and locking feature partly broken off and some damage likely occurred during the removal.No other observations can be made regarding the shell.Without product return, further visual and dimensional evaluations cannot be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.The reported products, liner, shell and head were reviewed for compatibility with no issues noted.However, it is unknown if the entire construct is compatible.A definitive root cause cannot be determined.The allegation of noise/squeaky hip cannot be confirmed.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: TRABECULAR METAL ACET SHELL 54MM CLUSTER
• Common Device Name: PROSTHETIC, 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: 20410998
• Report Number: 0001822565-2024-03220
• Device Sequence Number: 9070215
• Product Code: LZO
• UDI-Device Identifier: 00889024118911
• UDI-Public: (01)00889024118911(17)260531(10)63365704
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K021891
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

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: Lay User/Patient
• Device Expiration Date: 05/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 00-6202-054-22
• Device Lot Number: 63365704
• 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: 09/16/2024
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2016
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male