MAUDE Adverse Event Report: STRYKER REJUVENATE

Device Problem Metal Shedding Debris (1804)

Patient Problems Pain (1994); Swelling (2091); Tissue Damage (2104); Toxicity (2333); Reaction (2414); Test Result (2695)

Event Type  Injury  

Event Description

(b)(6), 2011, stryker mom hip implant right hip.Two months later pain starts back, over next few months had mars mri, bone scan, hip aspiration.First revision in (b)(6) 2012, metal toxins caused tumors, lots of tissue damage.In (b)(6) 2013, had second revision.In (b)(6) 2014, pain, swelling back.Had another mars mri and bone scan scheduled in 2 days.Facing a third revision.

• Brand Name: REJUVENATE
• Type of Device: REJUVENATE
• Manufacturer (Section D): STRYKER
• MDR Report Key: 3642663
• MDR Text Key: 4281454
• Report Number: MW5034636
• Device Sequence Number: 1
• Product Code: MEH
• 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: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 60 YR
• Patient Weight: 86