MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CR ILOK FEM-RT 62.5; PROSTHESIS KNEE

Model Number N/A

Device Problems Unstable (1667); Noise, Audible (3273)

Patient Problems Pain (1994); Discomfort (2330)

Event Type  Injury  

Event Description

It was reported patient is experiencing pain, instability and popping in knee approximately 3 years post implantation.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

(b)(4).Medical product: e1 vngd as tib brg 13x71 catalog # ep-189063 lot # 315520; biomet cc i-beam tray 71mm catalog # 141223 lot # j6453610; series a pat std 34 3 peg catalog # 184766 lot # 641100.Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001825034-2022-01661; 0001825034-2022-01673; 0001825034-2022-01675.

Manufacturer Narrative

H6: component code: mechanical g4-femur.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.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 Description

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

• Brand Name: VANGUARD CR ILOK FEM-RT 62.5
• 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: 15074333
• MDR Text Key: 296300627
• Report Number: 0001825034-2022-01669
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 00880304270398
• UDI-Public: (01)00880304270398(17)281225(10)J6462776
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 183006
• Device Lot Number: J6462776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/25/2018
• 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
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 77 KG