MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/+5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 6260-9-236

Device Problem Insufficient Information (3190)

Patient Problems Arthritis (1723); Death (1802); Pain (1994); Renal Failure (2041); Heart Failure (2206); Joint Disorder (2373); Ambulation Difficulties (2544)

Event Date 11/08/2016

Event Type  Death  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock on with no reported discrepancies.There have been no other events for the lot referenced.

Event Description

Patient's wife received a recall letter.The wife state the patient expired on (b)(6) 2016 cause of death was heart failure.She said he was in a lot of pain four to five months prior to his passing; he used a walker and cane.Left hip.

Manufacturer Narrative

Additional information: a(b)(6) weight units an event regarding patient factors involving a metal head was reported.The event was confirmed.Method & results: device evaluation and results: not performed as the device was not returned.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: ¿on (b)(6) 2007 a consultation noted a left hip screw placement in childhood, coronary artery disease with coronary bypass in his history, and x-rays noted a left hip end-stage osteoarthritis.[¿]on (b)(6) 2009 a left total hip arthroplasty and removal of hardware was performed for a diagnosis of severe degenerative joint disease of the left hip with retained hardware.[¿]on (b)(6) 2016 the patient was admitted with a diagnosis of bacterial pneumonia and bacteremia.He underwent intensive medical treatment for multiple medical conditions including "pre-renal failure, shortness of breath, dysmorphic liver, bile duct fibrosis, primary sclerosing cholangitis, concern for gi malignancy, chronic atrial fibrillation on warfarin, lasix and digitalis treatment for cardiac condition" while in the hospital, and on (b)(6) 2016 died.[¿] no documented follow-up between (b)(6) of 2009 and (b)(6) of 2016, no x-rays of the total hip arthroplasty, and no confirmation of symptoms related to his total hip are available for review.Based upon the information available for review there is no evidence that the patient who expired from cardiac disease nine years status-post left total hip arthroplasty was adversely impacted by his left hip surgery nor is there any evidence that he underwent a hip revision."-device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: the investigation concluded that the patient passed away due to cardiac disease.The medical review concluded, ¿based upon the information available for review there is no evidence that the patient who expired from cardiac disease nine years status-post left total hip arthroplasty was adversely impacted by his left hip surgery nor is there any evidence that he underwent a hip revision.¿ no further investigation for this event is possible at this time.If devices and/or additional information become available, this investigation will be reopened.

Event Description

Patient's wife received a recall letter.The wife state the patient expired on (b)(6) 2016 cause of death was heart failure.She said he was in a lot of pain four to five months prior to his passing; he used a walker and cane.Left hip.

• Brand Name: V40 COCR LFIT HEAD 36MM/+5
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: timothy rice ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6404621
• MDR Text Key: 69945954
• Report Number: 0002249697-2017-00908
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/20/2018

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: Health Professional
• Device Expiration Date: 03/31/2013
• Device Catalogue Number: 6260-9-236
• Device Lot Number: 90NMEE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/16/2017
• Initial Date FDA Received: 03/14/2017
• Supplement Dates Manufacturer Received: 02/20/2018
• Supplement Dates FDA Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2249697-08/29/2016-007R
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 83 YR
• Patient Weight: 81