MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN VANGUARD FEMORAL; PROSTHESIS, KNEE

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Hypersensitivity/Allergic reaction (1907); Damage to Ligament(s) (1952); Pain (1994); Scar Tissue (2060); Synovitis (2094); Discomfort (2330); Ambulation Difficulties (2544); Osteopenia/ Osteoporosis (2651)

Event Date 07/13/2022

Event Type  Injury  

Event Description

It was reported that a patient was revised approximately eleven and a half months post implantation due to allergic reaction to nickel.Attempts to obtain additional information have been made; however, no more information is available at this time.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2023-00903.D10-medical product: unknown vanguard tibial tray.H3- customer has not indicated whether the product will 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.

Event Description

It was reported that a patient was revised approximately eleven months post implantation due to pain, adl limitations, and tissue damage.This was primarily attributed by the surgeon to an allergic reaction/hypersensitivity to nickel which was a known condition.The initial components were replaced without any noted complications.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: revision procedure notes: patient now presents with pain and difficulty with day-to-day comfort and function; surgeon states, ¿i felt at this time that the nickel sensitivity was a major component to her somatic and mechanical difficulties¿ and ¿she has a known history of significant skin sensitivity to nickel containing jewelry.She has been tested for nickel sensitivity systemically, which was significant.¿; evidence of osteoporosis of the tibial stem.Device history record (dhr) review was unable to be performed as the part and lot number of the device involved in the event is unknown.The root cause of the allergic reaction is attributed to patient condition as they are allergic to nickel.A definitive root cause cannot be determined for the reported pain, bone loss, and scar tissue.If any further information is received which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.H6: component code: proposed component (annex g) code is: mechanical (g04) - femur.

• Brand Name: UNKNOWN VANGUARD FEMORAL
• 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: 16822736
• MDR Text Key: 314082488
• Report Number: 0001825034-2023-00902
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• 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: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Hospitalization
• Patient Sex: Female