MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_RECONSTRUCTIVE_PRODUCT; IMPLANT

Catalog Number UNK_REC

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Renal Failure (2041)

Event Date 02/18/2014

Event Type  Death  

Manufacturer Narrative

Catalog number is unknown at this time.The device was reported as an unknown rejuvenate/abg ii modular neck.Additional information has been requested and if received, will be provided in the supplemental report.Not returned.

Event Description

It was reported that "the caller stated that her husband (no name given) had had a hip replacement but had died 6 hours (date & time unclear) following his surgery.The caller stated that although her husband had diabetes, kidney failure and was on dialysis a ¿stryker doctor¿ and a cardiologist had told her everything would be ok.I have not had any calls related to this and therefore assume that the reference to a ¿stryker doctor¿ is in fact a surgeon who uses our implants.".

Event Description

It was reported that "the caller stated that her husband (no name given) had had a hip replacement but had died 6 hours (date & time unclear) following his surgery.The caller stated that although her husband had diabetes, kidney failure and was on dialysis a ¿stryker doctor¿ and a cardiologist had told her everything would be ok.I have not had any calls related to this and therefore assume that the reference to a ¿stryker doctor¿ is in fact a surgeon who uses our implants.".

Manufacturer Narrative

An event regarding revision involving an unknown rejuvenate/abgii modular device was reported.The event was confirmed.Device evaluation was not performed as no devices were received.History review of device records could not be performed as the reported device was not properly identified.Complaint history review.A search of the complaint databases could not be performed as the reported device was not properly identified.Similar events have occurred for the rejuvenate and abgii modular product families.These events were determined to be associated with ra 2012-067.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 is considered to be under the scope of this recall.No further investigation is required.

• Brand Name: UNKNOWN_RECONSTRUCTIVE_PRODUCT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: niku kasmai ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3775591
• MDR Text Key: 15879821
• Report Number: 0002249697-2014-01531
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/18/2014

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: Lay User/Patient
• Device Catalogue Number: UNK_REC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/02/2014
• Initial Date FDA Received: 04/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/03/2014
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other; Required Intervention