MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD CR TIB BRG 12X71/75; PROSTHESIS, KNEE

Catalog Number	183442
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	04/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial total knee arthroplasty on an unknown date.Subsequently, on an unknown timeframe post-implantation, the patient began to experience instability and underwent revision surgery due to wear of the articular surface.Due diligence is in progress for this event; to date no further information has been reported.
Additional Manufacturer Narrative
(b)(4).D10: medical product: unknown tibial component: catalog#ni, lot#ni; unknown femoral component: catalog#ni, lot#ni.G2: foreign: australia.The product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: a1; a2; a3; b4; b5; b7; d6a; d10; g3; h2; h6; h11.D10: medical product: unknown vanguard cr femoral component 70mm: catalog#ni, lot#ni; unknown 75mm regenerex tibial tray: catalog#ni, lot#ni.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial total knee arthroplasty.Subsequently, approximately eight (8) years post-implantation, the patient began to experience instability and underwent revision surgery due to wear of the articular surface.Due diligence is complete as multiple attempts have been made; all available information has been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h6; h11.Visual examination of the provided picture identified there is wear on the femoral mating surface of the articular surface.As the device was not returned, further evaluations could not be performed.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: initial operation notes: spinal with general anesthesia, medial parapatellar approach, trial reduction showed good range of motion with good stability.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: implant fit is maintained.Bone quality is osteopenic.Severe left knee arthroplasty valgus malalignment and anterior tibial dislocation as noted with suspected abnormal polyethylene wear.Root cause was unable to be determined.Reported event was confirmed by review of provided picture.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
No further event information at time of this report.

• Brand Name: VNGD CR TIB BRG 12X71/75
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19174150
• Report Number: 0001825034-2024-01067
• Device Sequence Number: 7455801
• Product Code: JWH
• UDI-Device Identifier: 00880304271142
• UDI-Public: (01)00880304271142(17)200528(10)199330
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 07/16/2024

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: Health Professional
• Device Expiration Date: 05/28/2020
• Device Catalogue Number: 183442
• Device Lot Number: 199330
• 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: 04/04/2024
• Supplement Date Received by Manufacturer: 05/14/2024; 07/16/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 06/07/2024; 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2015
• 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: .; .
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 88 YR
• Patient Sex: Female