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

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through a single case study publication that a patient underwent a left cruciate-retaining total knee arthroplasty on an unknown date.Approximately 10 months later, the patient presented with pain, tightness, and persistent swelling.Infection was ruled out, and a backed out locking bar was identified radiographically, which was also palpable subcutaneously.The patient underwent revision of the poly bearing and locking bar on an unknown date.During the revision, the bearing was downsized which provided a better overall fit.At final follow up, all symptoms had subsided, and the patient reported no further complications.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).(b)(6).Literature sharma a, killampalli v, patel a, locking mechanism failure between tibial baseplate and polyethylene insert in cruciate retaining total knee arthroplasty, journal of clinical orthopaedics and trauma (2022), doi: https://doi.Org/10.1016/j.Jcot.2022.102013 the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: 183028 - vanguard cr ilok fem-lt 65 - j6828862.141254 - polished finned tib tray 75mm - 2020031003.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
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.D10: 183028 - vanguard cr ilok fem-lt 65 - j6828862.141254 - polished finned tib tray 75mm - 2020031003.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 provided and reviewed by a health care professional.Review of the available records identified the following: 10 months post op patient developed pain in knee, persistent swelling noted, no restriction of rom, x-rays revealed locking bar backed out medially; pin was found renting through tissues and through medial soft tissue envelope, removed.Membrane was found between the articulations on both medial/lateral sides and removed.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.
Event or Problem Description
No further event information available at the 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: 15501249
• Report Number: 0001825034-2022-02189
• Device Sequence Number: 12724834
• Product Code: JWH
• UDI-Device Identifier: 00880304271142
• UDI-Public: (01)00880304271142(17)240517(10)393660
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/06/2023

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: 05/17/2024
• Device Model Number: N/A
• Device Catalogue Number: 183442
• Device Lot Number: 393660
• 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: 09/05/2022
• Supplement Date Received by Manufacturer: 09/25/2022; 01/04/2023
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 10/13/2022; 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2019
• 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
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female