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 Problems Break (1069); Material Separation (1562); Metal Shedding Debris (1804); Material Deformation (2976); Noise, Audible (3273)

Patient Problems Fall (1848); Complaint, Ill-Defined (2331); Injury (2348); Joint Dislocation (2374); Reaction (2414); Ambulation Difficulties (2544)

Event Date 01/03/2006

Event Type  Injury  

Event Description

It was reported through the filing of a lawsuit that allegedly the patient was walking when he spontaneously felt and heard a snap and pop in the area of is hip, lost his balance and fell to the ground without the ability to stand.It is further alleged during the revision surgery the surgeon noted " femoral component was significantly damaged around the trunnion and the femoral neck of the prosthesis and the femoral head was disengaged from the femoral component." there were also findings of "diffused metallosis" and "dark black and dark brown fluid.".

Manufacturer Narrative

The catalog number and lot code were not provided.The device was reported as an unknown lfit anatomi v40 femoral head.The information in this report was provided by stryker orthopaedics legal affairs.No additional information is available at this time due to ongoing litigation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Legal case.

Manufacturer Narrative

An event regarding disassociation involving a metal head was reported.The event was not confirmed.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: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: the event could not be confirmed nor the root cause determined as sufficient information was not provided.However, the subject device has been identified to be within scope of nc and capa.Lot specific voluntary recall ra 2016-028 was initiated for the lfit v40 cocr heads within scope of nc and 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 analyses identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.No further investigation is required.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient was walking when he spontaneously felt and heard a snap and pop in the area of is hip, lost his balance and fell to the ground without the ability to stand.It is further alleged during the revision surgery the surgeon noted " femoral component was significantly damaged around the trunnion and the femoral neck of the prosthesis and the femoral head was disengaged from the femoral component." there were also findings of "diffused metallosis" and "dark black and dark brown fluid.".

• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3939011
• MDR Text Key: 19296210
• Report Number: 0002249697-2014-02727
• 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: Other,Consumer,consumer,other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/14/2017

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: 06/07/2010
• Device Catalogue Number: 6260-9-236
• Device Lot Number: 30032401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/24/2014
• Initial Date FDA Received: 07/16/2014
• Supplement Dates Manufacturer Received: 10/17/2017
• Supplement Dates FDA Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2005
• 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