MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS CORK UNK LEFT REJUVENATE/ABG II HIP NECK; IMPLANT

Device Problem Nonstandard Device (1420)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Numbness (2415); Limited Mobility Of The Implanted Joint (2671)

Event Date 03/18/2012

Event Type  Injury  

Event Description

It was reported that: pt is experiencing extreme pain, numbness, and muscle spasms.Pt is also reporting that he is experiencing stiffness and soreness.Pt states that the pain started three months ago and it was localized but has since increased.Pt states that doctor wants mri to be scheduled.

Manufacturer Narrative

The catalog and lot number along with the device were not provided for investigation.The event was confirmed.A voluntary recall ra 2012-067 was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices.The reported event is considered to be under the scope of this recall.

• Brand Name: UNK LEFT REJUVENATE/ABG II HIP NECK
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS CORK; carrigtwohill county cork ; EI
• Manufacturer (Section G): STRYKER ORTHOPAEDICS CORK; ida industrial estate; carrigtwohill county cork ; EI
• Manufacturer Contact: keyla navedo ; 325 corporate dr; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3601341
• MDR Text Key: 16088848
• Report Number: 9616680-2014-00078
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/18/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: RA 2012-067
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 86