MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 6260-9-136

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Edema (1820); Failure of Implant (1924); Irritation (1941); Necrosis (1971); Pain (1994); Injury (2348); Reaction (2414)

Event Date 02/22/2011

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.Device not available.

Event Description

It was reported by the attorney for the patient as a result of a legal claim that allegedly the patient underwent primary surgery on the left hip on (b)(6) 2011.It alleged the patient sustained injuries as a result of the implanted devices.On (b)(6) 2011 the patient underwent a left total hip arthroplasty and was implanted with a citation tmzf femoral hip stem and a v40 femoral head.She began experiencing irritation and pain in her left hip.It is alleged that she developed a pseudotumor, had necrosis of the gluteus muscles, elevated cobalt level and was revised on (b)(6) 2015 with a pre and postoperative diagnosis of ¿failed left total hip arthroplasty secondary to head and neck corrosion with an adverse local tissue reaction.¿.

Manufacturer Narrative

An event regarding altr involving a metal head was reported.The event was not confirmed.Method & results: -device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.-medical records received and evaluation: no medical records or x-rays were made available for evaluation.-device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.-complaint history review: there has been no other event for the lot referenced.Conclusions: the event could not be confirmed nor the root cause determined because insufficient information was provided.Further information such as return of device, histopathology report & follow-up notes are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.

Event Description

It was reported by the attorney for the patient as a result of a legal claim that allegedly the patient underwent primary surgery on the left hip on (b)(6) 2011.It alleged the patient sustained injuries as a result of the implanted devices.On (b)(6) 2011 the patient underwent a left total hip arthroplasty and was implanted with a citation tmzf femoral hip stem and a v40 femoral head.She began experiencing irritation and pain in her left hip.It is alleged that she developed a pseudotumor, had necrosis of the gluteus muscles, elevated cobalt level and was revised on (b)(6) 2015 with a pre and postoperative diagnosis of ¿failed left total hip arthroplasty secondary to head and neck corrosion with an adverse local tissue reaction.¿.

• Brand Name: V40 COCR LFIT HEAD 36MM/0
• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6304269
• MDR Text Key: 66610343
• Report Number: 0002249697-2017-00467
• 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
• Type of Report: Initial,Followup
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: 6260-9-136
• Device Lot Number: MJPP88
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2010
• 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): Hospitalization; Required Intervention