MAUDE Adverse Event Report: MEDSHAPE EXOSHAPE

Device Problem Device Slipped (1584)

Patient Problems Pain (1994); Joint Swelling (2356)

Event Date 02/14/2012

Event Type  Injury  

Event Description

Exoshape fastener was used in my left tibia for an acl reconstruction.Two months after surgery, i had crippling pain in my tibia and constant swelling in my knee.I continued my rehabilitation and suffered for 9 more months before my surgeon would agree to remove it.Upon surgery, the exoshape actually popped free upon incision it was not anchored in the bone therefore pushing on my muscle, nerves and soft tissue.Immediate relief after surgery and swelling disappeared from my knee after a month.

• Brand Name: EXOSHAPE
• Type of Device: EXOSHAPE
• Manufacturer (Section D): MEDSHAPE
• MDR Report Key: 4438504
• MDR Text Key: 17997538
• Report Number: MW5040260
• Device Sequence Number: 1
• Product Code: MBI
• 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: 01/12/2015

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: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/12/2015
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 82