MAUDE Adverse Event Report: STRYKER CORP. STRYKER RADIAL HEAD REPLACEMENT; PROSTHESIS, ELBOW, HEMI, RADIAL, POLYMER

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Patient underwent radial head replacement with a stryker radial head on (b)(6) 2016.Approximately 2 years later, he was using his arm for a regular activity and had immediate pain.Xrays showed that the modular head had partially disengaged from the stem.

• Brand Name: STRYKER RADIAL HEAD REPLACEMENT
• Type of Device: PROSTHESIS, ELBOW, HEMI, RADIAL, POLYMER
• Manufacturer (Section D): STRYKER CORP.
• MDR Report Key: 8142333
• MDR Text Key: 129966272
• Report Number: MW5081942
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 107