MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VGD VE AS TIB BRG 71X14MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Pain (1994); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	07/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was revised approximately two years and four months post implantation due to pain, instability, effusions, and patella impingement with malalignment.Attempts to obtain additional information have been made; however, no more information is available.
Additional Manufacturer Narrative
(b)(4).D10- medical product: vanguard cr fem 65 rt-mach, item# 183008-01, lot# j6917396; series a pat std 25 3 peg, item# 184760, lot# 807800; biomet cc cruciate tray 71mm, item# 141233, lot# j6869986; bone scr 6.5x25 self-tap, item# 00625006525, lot# 64611734 x2; biomet bc r 1x40 us, item# 110035368, lot# f2701z12ba x2.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.The radiographs were not submitted as sufficient information was provided via the written medical records.Additional review of the radiographs would not enhance the investigation.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: small joint effusion negative for synovitis; moderate swelling; subluxation of patella with maltracking and impingement; no fracture or loosening identified; persistent pain and instability; femoral bone loss identified.It is mentioned in the revision notes that the patella was undersized; however, the size of the patella would have been chosen based on following surgical technique during the initial surgery and confirmed during trialing to check range of motion and stability of the knee.Therefore, no issues are found with the patella sizing.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot be determined.This complaint has been confirmed by review of the provided medical records.If any further information is found which would change or alter any conclusions or information, a supplemental medwatch will be filed accordingly.Zimmer biomet will continue to monitor for trends.Previously reported under incorrect mfr in (b)(4).

• Brand Name: VGD VE AS TIB BRG 71X14MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19710601
• Report Number: 0001822565-2024-02312
• Device Sequence Number: 8514501
• Product Code: JWH
• UDI-Device Identifier: 00889024564534
• UDI-Public: (01)00889024564534(17)240930(10)64469192
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K183583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/10/2024

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: 09/30/2024
• Device Model Number: N/A
• Device Catalogue Number: VE189064
• Device Lot Number: 64469192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 131 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American