MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRABECULAR METAL SHELL POROUS WITH MULTI HOLES 62 MM; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 00631006236 item name liner 10 degree elevated rim 3.5 mm offset 36 mm i.D.For use with 62 mm o.D.Shell lot # 64376430 g2: foreign: australia 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 1 year and 2 months post implantation due to a failure of a stryker product that was cemented into the mars shell.There is no additional information available at the time of this report.
Event or Problem Description
It was reported that the patient underwent a revision procedure 1 year and 2 months post implantation due to a disassociation of a stryker liner that was cemented into the tm cup.The cup remains implanted.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
There is no update to the prior event description provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.One photo was provide which shows a cup, screw protruding and bio on the sphere.No other information can be obtained from the photo.A review of the device history records identified no deviations or anomalies during manufacturing.The device is used for treatment.Medical records were not provided.The root cause of the reported issue is attributed to off-label use.Per ifu, only authorized combinations should be used.The event could not 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 SHELL POROUS WITH MULTI HOLES 62 MM
• 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: 19499200
• Report Number: 0001822565-2024-01936
• Device Sequence Number: 6652803
• Product Code: LPH
• UDI-Device Identifier: 00889024119017
• UDI-Public: (01)00889024119017(17)270430(10)63647916
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K021891
• 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): 10/03/2024

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00620206220
• Device Lot Number: 63647916
• 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: 05/13/2024
• Supplement Date Received by Manufacturer: 06/14/2024; 10/03/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 07/02/2024; 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2017
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 89 KG