MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VGXP XP INLK PRI TIB TRAY 67MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924)
Date of Event	01/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Foreign report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00280.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient had a total knee arthroplasty and subsequently was revised approximately 5 years after the initial procedure due to wear and fracture of the implant.Development of cysts was noted on medial tibia plateau.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).The complaint is confirmed.Visual examination of the provided pictures identified signs of being implanted wear / scratched / gouged and has cracked / fractured.The tibial tray was not returned.Review of the device history records identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: periprosthetic lucency noted surrounding at least 1 of the posterior tibial pegs indicative of loosening, suggested poly wear and loosening.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 event information available at the time of this report.

• Brand Name: VGXP XP INLK PRI TIB TRAY 67MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11307028
• Report Number: 0001825034-2021-00356
• Device Sequence Number: 16958008
• Product Code: MBH
• UDI-Device Identifier: 00880304553132
• UDI-Public: (01)00880304553132(17)240908(10)543250
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K132873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/08/2024
• Device Model Number: N/A
• Device Catalogue Number: 195753
• Device Lot Number: 543250
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/22/2021
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 03/23/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ITEM 195877 LOT 874800; ITEM 195877 LOT 874800
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 68