MAUDE Adverse Event Report: DEPUY SYNTHES JOINT RECONSTR DEPUY ORTHOPAEDICS

Lot Number 8383816

Device Problems Fracture (1260); Difficult to Remove (1528); Sticking (1597)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

A (b)(6) male admitted for right tkr.During the procedure, the piece of plastic that sits atop of the tibial component to prevent scratching of the femoral component during placement got caught on the component when placed.The bone cement used to hold the tibial component stuck to the plastic and a piece of the plastic could not be removed and remained in the knee.It was cemented under the lateral posterior condyle of the true femoral component.This was noted when the tibial polyethylene spacer was removed.It was not able to be removed without removing the entire femoral component.The implant was removed to prevent retention of the plastic covering and a new joint was reinserted.Upon extraction of the femoral component, the condyle fractured from the shaft with a soft tissue attachment remaining intact occurred which was later repaired.Depuy synthes orthopaedics tibial base plate size 8 implant inserted during procedure on (b)(6) 2017 was removed and wasted due to adverse event noted above.Therapy start date: (b)(6) 2017.Therapy end date: (b)(6) 2017.Diagnosis or reason for use (indication): right tkr.

• Brand Name: DEPUY ORTHOPAEDICS
• Type of Device: DEPUY ORTHOPAEDICS
• Manufacturer (Section D): DEPUY SYNTHES JOINT RECONSTR
• MDR Report Key: 6356186
• MDR Text Key: 68372277
• Report Number: MW5068088
• Device Sequence Number: 1
• Product Code: JWH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: No Information
• Device Lot Number: 8383816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 55