MAUDE Adverse Event Report: ZIMMER UNICOMPARTMENTAL HIGH FLEX PRECOAT

Lot Number 63408604

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Discomfort (2330); Ambulation Difficulties (2544)

Event Date 10/13/2017

Event Type  Injury  

Event Description

On (b)(6) 2017 received a zimmer unicompartmental high flex precoat (lot # 63408604) replacement of the left media/right lateral.In mid-late (b)(6) 2017 started noticing severe pain when initially standing and attempting to walk.Followup visit in (b)(6) resulted evaluation and followup visit in (b)(6) 2017 upon which told that appears device failure and full replacement recommended.Currently the situation has worsened where any standing results in sharp pain, limping when walking and varying levels of discomfort.

• Brand Name: UNICOMPARTMENTAL HIGH FLEX PRECOAT
• Type of Device: UNICOMPARTMENTAL HIGH FLEX PRECOAT
• Manufacturer (Section D): ZIMMER
• MDR Report Key: 7292572
• MDR Text Key: 100955323
• Report Number: MW5075458
• Device Sequence Number: 1
• Product Code: HSX
• 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: 02/21/2018

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
• Device Operator: Lay User/Patient
• Device Lot Number: 63408604
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 58 YR
• Patient Weight: 90