MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD POSTERIOR STABILIZED TIBIAL BEARING 10MM X 71/75MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	05/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant devices - vanguard posterior stabilized interlok femoral component left 70, catalog #: 183132, lot #: j3880066; biomet tibial tray 71mm, catalog #: 141223,  lot #: j6061624.The complainant has not yet indicated whether or not the devices will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001825034-2020-02687.Investigation incomplete.
Event or Problem Description
It is reported that the patient underwent a left knee arthroplasty revision to address pain, limited range of motion and limited mobility approximately one (1) year post-operatively.Attempts have been made and no additional information is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, b6, b7, g4, g7, h2, h3, h6, h10.The product was evaluated through manufacturing review and the reported event was confirmed through review of medical records.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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 is reported that the patient underwent a left knee manipulation and arthroscopic synovectomy with scar tissue removal to address pain, swelling, stiffness limited range of motion and limited mobility approximately ten (10) months post-operatively.The patient was diagnosed with arthrofibrosis and continued with physical therapy, which made slow improvements with range of motion.Initial operative notes did not identify any intraoperative complications.Operative notes from the arthroscopic procedure noted extensive arthrofibrosis throughout the knee with heavy scar tissue.However, no intraoperative complications were noted.Attempts have been made and no additional information is available at this time.

• Brand Name: VANGUARD POSTERIOR STABILIZED TIBIAL BEARING 10MM X 71/75MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10257679
• Report Number: 0001825034-2020-02688
• Device Sequence Number: 16854605
• Product Code: JWH
• UDI-Device Identifier: 00880304271937
• UDI-Public: (01)00880304271937
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K023546
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2020

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: 06/22/2022
• Device Model Number: N/A
• Device Catalogue Number: 183640
• Device Lot Number: 040510
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 07/26/2020
• 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: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 70