MAUDE Adverse Event Report: ZIMMER TMT TMARS 50MM X 10MM THICKNESS ACETABULAR AUGMENT; PROSTHESIS, HIP

Catalog Number	00489405010
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	11/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: trabecular metal acetabular revision system, column buttress, left posterior / right anterior: catalog# 00489430000, lot# 64532856; g7 10 deg e1 liner 36 mm e: catalog# 010000896, lot# 6694887; g7 osseoti multihole 52 mm e: catalog# 110010264, lot# 7426938; bone screw self-tapping 6.5 mm dia.20 mm length: catalog# 00625006520, lot# j6872908; bone screw self-tapping 6.5 mm dia.30 mm length: catalog# 00625006530, lot#j6915128; bone screw self-tapping 20 mm length 6.5 mm dia.: catalog# 00662406520, lot# 62460740; bone screw self-tapping 20 mm length 6.5 mm dia.: catalog# 00662406520, lot# 62641023; bone screw self-tapping 20 mm length 6.5 mm dia.: catalog# 00662406520, lot# 64257747; bone screw self-tapping 30 mm length 6.5 mm dia.: catalog# 00662406530, lot# 65270239, qty#2; bone screw self-tapping 40 mm length 6.5 mm dia.: catalog# 00662406540, lot# 63704581.G2: foreign: event occurred in australia.H10: this device was erroneously reported under an incorrect complaint file and is now being submitted under an updated complaint file.See original report 3005751028-2024-00005.Visual examination of the provided pictures identified the explanted shell with bio-debris and what appears to be bone ingrowth on the surface.Pictures of the screws, augment, and buttress were not provided.No further evaluation can be made.The device history record was reviewed and no discrepancies relevant to the reported event were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: ct images of the left hip demonstrating anatomic alignment of the arthroplasty components but without solid bridging of the acetabular implant and cement noted consistent with implant loosening.In follow up, the surgeon noted space between acetabular component and host bone - no ingrowth or on growth present.It is not likely cement is in this construct as assumed by a third party professional.Furthermore, the device has a porous coating and does not show cement residue in the provided explant pictures.The reported event was confirmed by review of provided radiographs.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that the patient underwent a hip arthroplasty.Subsequently, the patient was revised approximately 16 months post-implantation due to loosening.Attempts have been made and no further information has been provided.

• Brand Name: TMARS 50MM X 10MM THICKNESS ACETABULAR AUGMENT
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer (Section G): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24875201
• Report Number: 3005751028-2026-00025
• Device Sequence Number: 10029293
• Product Code: LPH
• UDI-Device Identifier: 00889024306769
• UDI-Public: (01)00889024306769(17)250131(10)64578576
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042871
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/14/2026

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: 01/31/2025
• Device Catalogue Number: 00489405010
• Device Lot Number: 64578576
• 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: 04/13/2026
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2020
• 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