MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL ACETABULAR REVISION SYSTEM,COLUMN BUTTRESS,RIGHT POSTERIOR; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Osteolysis (2377); No Information (3190)
Date of Event	12/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated product and mdrs: 00700005020 trabecular metal acetabular revision shell lot# 64125372.Mdr: 3005751028-2021-00002.
Event or Problem Description
It was reported the revision surgery was performed.Tmars system (cup and column implant) was removed.The patient is waiting for triflange cup.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies related to the event during manufacturing.Images were provided and reviewed: image 1: there is disruption of the medial wall of the acetabulum with displacement of the loose acetabular cup medially and medial displacement of the proximal femur.The components are dislocated.There is suspected osteolysis of the acetabulum.Image 2: there has been interval revision with placement of a flanged acetabular implant with screw fixation.Alignment appears anatomic.Image 3: the acetabular implant is loosened and displaced medially as is the proximal femur.The components are dislocated.The medial wall of the acetabulum is disrupted.The patient is osteopenic.There is suspected underlying osteolysis.While implant loosening and displacement/dislocation occurred twice as described, there is no evidence of intrinsic device failure.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 ACETABULAR REVISION SYSTEM,COLUMN BUTTRESS,RIGHT POSTERIOR
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 11225426
• Report Number: 3005751028-2021-00003
• Device Sequence Number: 3607241
• Product Code: LPH
• UDI-Device Identifier: 00889024306998
• UDI-Public: (01)00889024306998(17)220930(10)6372440
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K061067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 00489440000
• Device Lot Number: 63724450
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/30/2020
• Supplement Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention