MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD CR TIB BRG 10X63/67; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Joint Laxity (4526)
Date of Event	10/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 141221 - biomet cc i-beam tray 63mm - j3871554, 183022 - vanguard cr ilok fem-lt 57.5 - 722670, 402282 - cobalt hv bone cement 40g - 058600, 184784 - series a pat thn 31 3 peg - 987190.The customer has indicated that the product will not 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 event, please see associated reports: 0001825034-2021-01138, 0001825034-2021-01140.
Event or Problem Description
It was reported by legal that a patient underwent initial bilateral total knee arthroplasties.Subsequently, the patient underwent a left knee revision due to pain, tibial loosening, instability, and loss of function approximately 1.5 years later.Intraoperatively, it was found that the cement had de-bonded from the tibial component.The initial zb patella was retained, remaining devices were removed, and competitor product was placed.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
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 health care professional.A review of the available records identified the following: no complication noted during the initial surgery.Then, the patient presented with tibial loosening and instability.During the surgery, the surgeon noted that the tibial was removed with minimal effect and no bone cement was adhere to the tibial plate.Scar tissue was noted both in femoral and tibial side and it was removed.Patella and femoral were well fixed, but the femoral was also revised during the surgery.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: VNGD CR TIB BRG 10X63/67
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11699309
• Report Number: 0001825034-2021-01137
• Device Sequence Number: 11677239
• Product Code: JWH
• UDI-Device Identifier: 00880304271050
• UDI-Public: (01)00880304271050(17)220219(10)748220
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

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: 02/19/2022
• Device Model Number: N/A
• Device Catalogue Number: 183420
• Device Lot Number: 748220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 05/21/2021
• 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; Required Intervention