MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS CORK UNK REJUVENATE/ABGII NECK; IMPACT

Device Problems Nonstandard Device (1420); Metal Shedding Debris (1804); Patient-Device Incompatibility (2682)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Toxicity (2333); Fluid Discharge (2686); Test Result (2695)

Event Date 04/01/2012

Event Type  Injury  

Event Description

It was reported that: patient said that he learned about the recall from the internet.According to the patient, "after confronting his doctor, he finally came clean".He stated that he has extreme pain radiating from his thigh to foot since (b)(6) 2012.He had fluid build up.The doctor aspirated 15cc one time from his hip.He has local tissue reaction.He has pain in the buttocks and groin areas.He has pain sitting down, feels like "sitting on bunch of rocks".He has elevated cobalt level.The patient was revised.

Manufacturer Narrative

An event regarding revision due to altr was reported.The event was confirmed.Method and results: device evaluation and results: inspection of the reported devices could not be performed as no items were returned.; device history review could not be performed as the reported devices were not properly identified.Complaint history review: the product experience reporting database shows there have been similar events reported for the product family.This issue has been previously investigated and addressed.Conclusions: 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 revision due to altr is considered to be under the scope of this recall.No further investigation is required.

• Brand Name: UNK REJUVENATE/ABGII NECK
• Type of Device: IMPACT
• 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 corp. dr.; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4452637
• MDR Text Key: 16995150
• Report Number: 9616680-2015-00005
• 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
• Type of Report: Initial
• Report Date: 09/07/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 41