MAUDE Adverse Event Report: STRYKER MEMOMETAL TOE IMPLANTS

Device Problem Break (1069)

Patient Problems Scar Tissue (2060); Burning Sensation (2146)

Event Date 12/17/2014

Event Type  Injury  

Event Description

I had three stryker memometal toe implants placed in 3 toes.One broke 2 weeks after surgery.They had to go in and do another surgery.Then 3 weeks later, the second implant broke.They had to go in and dig out the implant.We waited an entire year for the third implant to be take out (did not break yet, felt an infrequent burning sensation), yet we couldn't take any changes.I have been left with severely scarred toes, and the three toes have to much scar tissue, i am unable to bend them properly.The toes look mangled and my feet will never be the same.

• Brand Name: MEMOMETAL TOE IMPLANTS
• Type of Device: TOE IMPLANTS
• Manufacturer (Section D): STRYKER
• MDR Report Key: 5409557
• MDR Text Key: 37543821
• Report Number: MW5059975
• Device Sequence Number: 1
• Product Code: LZJ
• 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: 01/13/2016
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 93