MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E1 VNGD CR TIB BRG 71/75 X 13; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 141205 - biomet tibial locking bar - 244240.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the patient underwent a left partial knee procedure in 2004 of unknown product.Subsequently, patient was revised in 2015 due poly wear.At this time, the patient underwent a bilateral knee procedure, in which the patient was implanted with zimmer biomet product.Approximately 4 years later, the patient underwent a right knee revision due to swelling and fluid on the cap.The patient stated the poly had worn down to where the metal implants were rubbing together.He stated the poly had broken down so much the surgeon was picking plastic pieces out of his calf.Subsequently, the patient stated he has pain in his calf again and xrays show the poly has broken down again and is being considered for another revision.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product or photographs was returned; visual and dimensional evaluations could not be performed.The dhr was reviewed and no discrepancies relevant to the reported event were found.No medical records were provided.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.
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.X-ray review by mmi suggest polyethylene wear with moderate joint effusion.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.

• Brand Name: E1 VNGD CR TIB BRG 71/75 X 13
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11914473
• Report Number: 0001825034-2021-01660
• Device Sequence Number: 3633223
• Product Code: JWH
• UDI-Device Identifier: 00880304647817
• UDI-Public: (01)00880304647817(17)231215(10)557160
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,health p
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2021

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: 12/15/2023
• Device Model Number: N/A
• Device Catalogue Number: EP-183443
• Device Lot Number: 557160
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 06/16/2021; 07/08/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 07/07/2021; 07/09/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 90