MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VAN PS OPEN INTL FEM-RT 62.5; PROSTHESIS, KNEE

Model Number	183106
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Malposition of Device (2616)
Health Effect - Clinical Codes	Failure of Implant (1924); Reaction (2414)
Date of Event	12/08/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr's are associated with this reporting.Please also reference: 1825034-2016-01524.The investigation is in process.Once the investigation has been completed, a follow-up/final report will be submitted.Not returned to manufacturer.
Event or Problem Description
It was reported the patient was revised due to cement loosening causing device malposition and allergic reaction.It should be noted the cement is a competitor device.No further information has been made available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: h2, h3, h6, h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no related deviations or anomalies during manufacturing.Lab reports provided for inflammation pre-revision and anticoagulation monitoring post-revision.A definitive root cause cannot be determined.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
No further information available at the time of this reporting.

• Brand Name: VAN PS OPEN INTL FEM-RT 62.5
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9607977
• Report Number: 0001825034-2020-00308
• Device Sequence Number: 2738627
• Product Code: MBV
• UDI-Device Identifier: 00880304270787
• UDI-Public: 00880304270787
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2020

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: 01/13/2025
• Device Model Number: 183106
• Device Catalogue Number: 183106
• Device Lot Number: 882840
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 01/20/2020
• Supplement Report FDA Received Date: 01/22/2020
• 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: 141223 TIB TRAY, LOT J3513122
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention