MEMOMETAL TOE IMPLANTS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-31 for MEMOMETAL TOE IMPLANTS manufactured by Stryker.

Event Text Entries

[37543821] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5059975
• MDR Report Key: 5409557
• Date Received: 2016-01-31
• Date of Report: 2016-01-13
• Date of Event: 2014-12-17
• Date Added to Maude: 2016-02-04
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: MEMOMETAL TOE IMPLANTS
• Generic Name: TOE IMPLANTS
• Product Code: LZJ
• Date Received: 2016-01-31
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: STRYKER

Device Sequence Number: 2

• Brand Name: MEMOMETAL TOE IMPLANTS
• Generic Name: TOE IMPLANTS
• Product Code: LZJ
• Date Received: 2016-01-31
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: STRYKER

Device Sequence Number: 3

• Brand Name: MEMOMETAL TOE IMPLANTS
• Generic Name: TOE IMPLANTS
• Product Code: LZJ
• Date Received: 2016-01-31
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: STRYKER

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2016-01-31