MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E1 VNGD AS TIB BRG 10X79; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	12/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 184768 - patella - 266560, 183012 - femoral component - j3811647, 141205 - tibial locking bar - 244200, 141235 - tibial tray - j6428643, 110034355 - refobacin bc r 1x40 us - 745eah2108, 110034355 - refobacin bc r 1x40 us - 731bae2909.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was discarded.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 event, please see associated reports: 0001825034-2020-00667.
Event or Problem Description
It was reported that the patient underwent manipulation under anesthesia approximately three months post implantation to help with range of motion.The patient also noted that he felt knee popping which was accompanied by pain and swelling.Subsequently, the patient underwent revision approximately six months after the manipulation under anesthesia due to continued pain, recurrent range of motion issues, and patellar subluxation.
Additional Manufacturer Narrative
No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a healthcare professional.Patient presented patellar pain, patella subluxes and poor rom.Patient was revised due to dislodging of the patella.During the revision procedure, tibial and femoral components were well-fixed and were not revised.Patella was loose and the bearing was removed only due to exposure.No abnormalities noted on the bearing surface.Rom was restored.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: E1 VNGD AS TIB BRG 10X79
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9701802
• Report Number: 0001825034-2020-00668
• Device Sequence Number: 19259677
• Product Code: JWH
• UDI-Device Identifier: 00880304465855
• UDI-Public: 00880304465855
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2020

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: 10/08/2023
• Device Model Number: N/A
• Device Catalogue Number: EP-189100
• Device Lot Number: 712340
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 03/30/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 112