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

Catalog Number 6260-9-236

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 06/12/2017

Event Type  Injury  

Manufacturer Narrative

The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.Lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of a capa.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before march 4, 2011.The root cause analysis identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.Not available.

Event Description

It was reported by the attorney that plaintiff underwent a total hip arthroplasty on (b)(6) 2008 and had to undergo revision surgery on (b)(6) 2017 due to alleged head disassociation (hd).

• Brand Name: V40 COCR LFIT HEAD 36MM/+5
• Type of Device: HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
• 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: evelyn ryan ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8273980
• MDR Text Key: 133973970
• Report Number: 0002249697-2019-00320
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327032314
• UDI-Public: 07613327032314
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173499
• 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
• Report Date: 01/24/2019

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: 03/31/2012
• Device Catalogue Number: 6260-9-236
• Device Lot Number: D63MED
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/27/2018
• Initial Date FDA Received: 01/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2007
• 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): Hospitalization; Required Intervention