MAUDE Adverse Event Report: ZIMMER BIOMET ZIMMER PERFORMS KNEE REPLACEMENT SYSTEM; "PROSTHESIS, KNEE, FEMORO TIBIAL, SEMI-CONSTAINED, CEMENTED, METAL/POLYMER

Model Number EDI: 42511400816

Device Problems Inadequacy of Device Shape and/or Size (1583); Unstable (1667)

Patient Problem Pain (1994)

Event Date 03/04/2019

Event Type  Injury  

Event Description

Zimmer performa 16 mm knee implant spacer too short, knee unstable causing pain.Surgeon ordered 19mm spacer for proper fit, can't be made, not fda approved.If approved 22mm spacer too big, will necessitate using a thinner spacer and replacing the tibial plate with a thicker one.This requires unnecessary additional surgery and increases my recovery time to 8 weeks from two, plus added pain and discomfort.The femur cap has many different sizes in small increments to cover various applications.Why is the spacer restricted to so few choices? why, if use in a range from 16 to 22 mm is approved, is an intermediate size not approved? i can't be the only ¿off the rack¿ case; surely, intermediate size spacers would be as functional as their larger and smaller counterparts.They are easily made and would significantly reduce surgery time, costs, recovery time, pain, and increase positive outcomes.Please approve intermediate spacer sizes asap.My corrective surgery is in may.

• Brand Name: ZIMMER PERFORMS KNEE REPLACEMENT SYSTEM
• Type of Device: "PROSTHESIS, KNEE, FEMORO TIBIAL, SEMI-CONSTAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): ZIMMER BIOMET
• MDR Report Key: 8392384
• MDR Text Key: 137952489
• Report Number: MW5084651
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EDI: 42511400816
• Device Lot Number: 62833033
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 98