MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD SSK PSC TIB BRG 18X63/67 7 X 18; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Positioning Failure (1158); Off-Label Use (1494)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a total knee arthroplasty, the bearing would not mate with corresponding femur implant.It was believed that this device was compatible with the corresponding implants.When the surgeon could not get a proper fit, they sawed off part of the post on this device to adjust the fit.There was a surgical delay of 30 minutes and it's been reported that the patient is waiting for the correct implant, indicating a revision is likely to occur.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Customer 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.Report source: (b)(6).Concomitant products: cp113123, vngd ti fem ssk 60mm lt, lot 934750; 141205, biomet tibial locking bar, lot 602980.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product or pictures were provided, as the device remains implanted.Review of the device history records identified no related deviations or anomalies during manufacturing.The reported products were reviewed for compatibility and it was determined that items 183868 (vngd ssk psc tib brg 18x63/67 7 x 18) and 185184 (vngd ssk 360 psc tib brg 18x59 18x59mm) are not compatible with item cp113123 (vngd ti fem ssk 60mm lt).The root cause of the reported issue is attributed to the off-label use of devices, as vanguard psc bearings are not compatible with the ssk femur used.It is unknown if this off-label use caused or contributed to the additional issue with the bending of the locking bar noted during removal.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.
Event or Problem Description
It was reported that during a total knee arthroplasty, the bearing would not mate with corresponding femur implant.It was believed that this device was compatible with the corresponding implants.When the surgeon could not get a proper fit, they sawed off part of the post on this device to adjust the fit.There was a surgical delay of 30 minutes and it's been reported that the patient is waiting for the correct implant, indicating a revision is likely to occur.Further follow-ups state that the patient will not undergo a revision, as they are satisfied with the knee at this time.No harm or impact has occurred.No additional information is available.

• Brand Name: VNGD SSK PSC TIB BRG 18X63/67 7 X 18
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13659372
• Report Number: 0001825034-2022-00415
• Device Sequence Number: 16630528
• Product Code: JWH
• UDI-Device Identifier: 00880304440838
• UDI-Public: (01)00880304440838(17)231031(10)960830
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 07/07/2022

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 Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 183868
• Device Lot Number: 960830
• 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: 02/09/2022
• Supplement Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown