MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD ANT STBLZD BRG 14X83; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Year of birth: (b)(6).Concomitant medical devices: 141236 j6279520 biomet cc cruciate tray 83mm.Foreign country: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 00408.
Event or Problem Description
It was reported the patient underwent initial knee arthroplasty on unknown date.Subsequently; the locking bar released from the tibia base plate and wedged between the inlay and femur.The inlay was revised.The tibia base plate remains implanted.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned locking bar found the clip has fractured off and there are surface scratches.Examination of the returned bearing found signs of wear and the fractured piece of the locking bar is lodged in the bearing.Locking bar was submitted for further analysis.Analysis determined the features of the locking bar surface wear patterns appear to reach the corner relief feature, possibly indicating the locking bar was fully engaged.Clasp tip could not be evaluated since it is lodged in the articular surface.Fatigue striations of the fracture surface suggest fatigue failure mode.Xrf analysis found the locking bar material is consistent with ti6-4 titanium alloy.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.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 ANT STBLZD BRG 14X83
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11305674
• Report Number: 0001825034-2021-00409
• Device Sequence Number: 17071727
• Product Code: JWH
• UDI-Device Identifier: 00880304437302
• UDI-Public: (01)00880304437302
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/07/2021
• Device Model Number: N/A
• Device Catalogue Number: 189124
• Device Lot Number: 651800
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 02/18/2021; 04/21/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 02/23/2021; 04/29/2021
• 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