MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E1 VNGD PS TIB BRG 63/67X10; IMPLANT, KNEE

Catalog Number	EP-183620
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an initial total knee arthroplasty, the articular surface was not able to lock onto the tibial tray.A replacement implant was used to complete the procedure.There was no surgical delay and no patient impact was reported as a result of the malfunction.
Additional Manufacturer Narrative
(b)(4).D10: medical product: biomet cc i-beam tray 67mm: catalog#141222, lot#j6997058.G2: foreign: china.The product has been received by zimmer biomet and the investigation is in process.Upon completion of the investigation, a follow-up mdr 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.Visual evaluation of the returned bearing found signs of use (nicks, gouges, tool marks).The tibia tray was implanted and not returned to evaluate for a fit/mate issue.A backup bearing was utilized with no issues reported.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were not provided.A definitive root cause cannot be determined.This complaint cannot be confirmed.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.

• Brand Name: E1 VNGD PS TIB BRG 63/67X10
• Common Device Name: IMPLANT, 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: 18358468
• Report Number: 0001825034-2023-03006
• Device Sequence Number: 8015667
• Product Code: JWH
• UDI-Device Identifier: 00880304465787
• UDI-Public: (01)00880304465787(17)270712(10)620360
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: EP-183620
• Device Lot Number: 620360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2023
• 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: 11/28/2023
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2022
• 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: SEE H10 NARRATIVE.
• Patient Sex: Female
• Patient Weight: 70 KG