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

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Date of Event	05/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-03935, 0001825034-2020-03936, 0001825034-2020-03963, and 0001825034-2020-03964.Medical devices: vgxp xp e1 tib brg rm 11x63 catalog#: 195844 lot#: 641580, vgxp intlk femoral rt 62.5 catalog#: 195909 lot#: 758590, vgxp xp e1 tib brg rl 9x63 catalog#: 195772 lot#: 852680, series a pat std 31 3 peg catalog#: 184764 lot#: 236110.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.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 that patient is experiencing pain approximately five years after implantation.No revision procedure has been reported.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
It was reported the patient underwent a right knee revision approximately two and a half years post-implantation due to pain and loosening of the tibial tray.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: b4, g3, g6, h2, h3, h6, and h10.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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
No further event information available at the time of this report.
Event or Problem Description
It was reported the patient underwent a right knee revision approximately two and a half years post-implantation to address pain, swelling, ambulation difficulties, instability and loosening of the tibial tray.Initial operative notes did not identify any intraoperative complications.Revision operative notes note the patient was revised due to pain and aseptic loosening with no intraoperative complications were identified.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.No devices were received; therefore the condition of the components is unknown.Device history record (dhr) was reviewed and no discrepancies were found.Primary surgery state no intra-operative complication.Revision operative notes state that patient underwent revision tka due to pain and aseptic loosening with all components exchanged with competitor product without complications or significant findings noted.Office notes (dated :(b)(6) 2016 to (b)(6) 2018) stated that patient had severe pain, swelling, hemarthrosis, instability and difficulty walking.X-ray review (dated: (b)(6) 2018) states that tka components in near-anatomic alignment, thin lucency along the undersurface of the tibial tray anteriorly and laterally but within normal limits without definitive osteolysis.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: 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: 10763911
• Report Number: 0001825034-2020-03937
• Device Sequence Number: 14286357
• Product Code: MBH
• UDI-Device Identifier: 00880304553132
• UDI-Public: (01)00880304553132(17)240302(10)206970
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K132873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/22/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/02/2024
• Device Model Number: N/A
• Device Catalogue Number: 195753
• Device Lot Number: 206970
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 11/04/2020; 03/01/2021; 04/23/2021; 10/18/2021
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 11/30/2020; 03/05/2021; 05/14/2021; 10/25/2021
• 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: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Weight: 84