MAUDE Adverse Event Report: STRYKER CORMET HIP PROSTHESIS RESURFACING; PROSTHESIS, HIP RESURFACING

Model Number CORMET 44 HEAD, 50 SHELL HYBRID

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Toxicity (2333)

Event Date 01/18/2018

Event Type  Injury  

Event Description

Revision surgery required for stryker corment tip resurfacing done in (b)(6) 2009, due to pain and high cobalt and chromium levels.

• Brand Name: CORMET HIP PROSTHESIS RESURFACING
• Type of Device: PROSTHESIS, HIP RESURFACING
• Manufacturer (Section D): STRYKER
• MDR Report Key: 7327081
• MDR Text Key: 102098090
• Report Number: MW5075768
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• 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: 03/08/2018

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 Model Number: CORMET 44 HEAD, 50 SHELL HYBRID
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: VITAMINS
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 53 YR
• Patient Weight: 57