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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Weakness (1967); Pain (1994); Loss of Range of Motion (2032); Numbness (2415); Ambulation Difficulties (2544); Balance Problems (4401); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

It was reported that patient underwent a right knee arthroplasty.Subsequently, patient has been experiencing pain, difficulty walking, unsteady balance, swelling, numbness, weakness, and difficulty to fully extend the implanted knee.No revision procedure has been reported.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-01642, 0001825034-2022-01644, and 0001825034-2022-01645.Medical devices: vanguard cr ilok fem-rt 62.5 catalog#: 183006 lot#: ni.Biomet ilok pri tib tray 67mm catalog#: 141212 lot#: ni.Bmet arcom ap pat w/wire 28mm catalog#: 11-150825 lot#: ni.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

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.Primary operative notes do not indicate any intra operative complications.Office notes state patient is experiencing moderate difficulty walking a mile, performing heavy activities around home and slight difficulty performing usual work, housework, and light activities.Patient reports pain, swelling, and difficulty walking, fatigue/weakness, stiffness, right lower extremity feels longer than left, numbness, stiffness, poor balance and inability to fully straighten leg.Rom 0-110; knee extension slightly limited at end of range of extension with arom.X-ray review by mmi states that anatomic alignment of the knee arthroplasty without acute abnormality or implant loosening.Bone quality appears osteopenic.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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 Description

No further event information available at the time of this report.

• Brand Name: VNGD CR LIP TIB BRG 10X63/67
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15042000
• MDR Text Key: 296064035
• Report Number: 0001825034-2022-01643
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 183520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Other
• Patient Sex: Female