MAUDE Adverse Event Report: HOWMEDICA OSTEONICS CORP., AKA STRYKER ORTHOPEDICS REJUVENATE HIP SYSTEM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Model Number SPT-070000S

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Toxicity (2333)

Event Date 12/11/2015

Event Type  malfunction  

Event Description

Patient brought to our hospital for removal of rejuvenate hip implants due to increased serum cobalt and chromium blood levels.

• Brand Name: REJUVENATE HIP SYSTEM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): HOWMEDICA OSTEONICS CORP., AKA STRYKER ORTHOPEDICS; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 5331595
• MDR Text Key: 34542835
• Report Number: 5331595
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SPT-070000S
• Other Device ID Number: #7
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/22/2015
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR