MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL 56MM CUP SIZE REVISION SHELL; PROSTHESIS, KNEE

Catalog Number	00700005620
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Aseptic loosening (4883)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a hip surgery.Subsequently the patient is experiencing pain and is planning to be revised due to a loose cup.The revision date has not yet been scheduled.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 00489405810 - trabecular metal acetabular revision system acetabular augment - 63392067; 00625006550 - bone screw self-tapping 6.5 mm dia.50 mm length - 64561604; 00662406550 - bone screw self-tapping 50 mm length 6.5 mm dia.- 63704590; 00662406540 - bone screw self-tapping 40 mm length 6.5 mm dia.- 64645209; 11-300814 - arcos 14 x 150 mm spl tpr dist - 774180; 11-300818 - arcos 18 x 150 mm spl tpr dist - 147420; 010000903 - g7 10 deg e1 liner 40 mm f - 3743858; 11-301331 - arcos con sz a hi 70 mm - 138850; 650-1058 - cer bioloxd option hd 40 mm - 2993268; 650-1067 - cer option type 1 tpr sleve +3 - 3031106.H10: this device was erroneously reported under an incorrect mfr, and is now being submitted under the appropriate mfr.See original report 0001822565-2024-02532.The event cannot be confirmed.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were not provided.A definitive root cause cannot 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.

• Brand Name: TRABECULAR METAL 56MM CUP SIZE REVISION SHELL
• Common Device Name: PROSTHESIS, KNEE
• 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: 24835392
• Report Number: 3005751028-2026-00023
• Device Sequence Number: 9222697
• Product Code: LPH
• UDI-Device Identifier: 00889024310872
• UDI-Public: (01)00889024310872(17)241130(10)64564812
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K003181
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2026

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: 11/30/2024
• Device Catalogue Number: 00700005620
• Device Lot Number: 64564812
• 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: 03/19/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2020
• 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.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female