MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD XP CRUCIATE RETAINING INTERLOK TIBIAL TRAY 67MM WITH LOCKING BAR; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	07/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following right knee arthroplasty, the patient is experiencing pain and migration of the tibial locking bar approximately two (2) years post-operatively.A revision procedure is planned at this time; however, no revision procedure has been reported to date.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
(b)(4).Concomitant medial devices - vanguard xp e1 tibial bearing right medial 10mm x 63mm catalog #: 195843 lot #: 016450, vanguard xp e1 tibial bearing right lateral 10mm x 63mm catalog #: 195773.Lot #: 645510, vanguard interlok femoral component right 60mm catalog #: 195908 lot #: 066550.Report source: (b)(6).The complainant has indicated that the product will not be returned to zimmer biomet for investigation as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6; h10 visual inspection of the returned locking bar exhibits signs of being implanted (nicks, gouges) and dimensional analysis found it to be within specifications.The sem report references a zrm for the analysis of locking bar.The zrm states that even though the examined locking bar contact mark and deformation observations are consistent with the bars not being fully engaged with the tibial tray lugs, it cannot be determined with certainty whether the reported locking bar dissociations occurred due to improper insertions.A more definitive conclusion would require analysis of not just the locking bars, but also of the mating tibial trays as well as the implanted bearings.The bar material was verified by xrf to be ti6-4.The device history record was reviewed and no discrepancies relevant to the reported event were found.X-ray review by third party hcp states that the locking bar backed out and extending medial to the medial compartment joint space.Bone quality is normal.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
It was reported that the patient underwent a right knee arthroplasty revision to address pain and migration of the tibial locking bar approximately two (2) years post-operatively.Only the locking bar was removed and replaced.Attempts have been made, however, no additional information is available.

• Brand Name: VANGUARD XP CRUCIATE RETAINING INTERLOK TIBIAL TRAY 67MM WITH LOCKING BAR
• 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: 15165275
• Report Number: 0001825034-2022-01770
• Device Sequence Number: 11917920
• Product Code: JWH
• UDI-Device Identifier: 00880304553149
• UDI-Public: (01)00880304553149(17)291017(10)162930
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• 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): 12/01/2022

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 Model Number: N/A
• Device Catalogue Number: 195271
• Device Lot Number: 162930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/14/2022
• Supplement Date Received by Manufacturer: 08/18/2022; 11/29/2022
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 09/13/2022; 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose