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 Degraded (1153); Device Markings/Labelling Problem (2911); Material Integrity Problem (2978); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Pain (1994); Injury (2348)

Event Date 10/07/2015

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that the patient had knee pain after twisting and was non weightbearing.Doctor took look at patient's current hip and noticed marks on femoral neck so decided to remove stem and liner.Both stem and liner were well fixed.

Manufacturer Narrative

An event regarding pain was reported.The event was confirmed for disassociation following material analysis.Method & results: -device evaluation and results: visual inspection: a visual inspection was performed as part of the material analysis report.This visual inspection stated that: the parts were examined with the aid of a stereo microscope at magnifications up to 50x.Scratches were observed on the articulating surface of the v40 head.Damage was observed on the distal rim and taper of the v40 head.This damage was likely caused by movement between the head taper and accolade stem trunnion.Debris was observed at the proximal end of the taper in the v40 head.Dimensional inspection: not performed as there were no allegations in relation to device dimensions.Functional inspection: not performed as alleged issue could not be replicated.The material analysis report concluded that damage was observed on the accolade trunnion and v40 head taper.This damage and wear was likely caused by movement between the head taper and accolade stem trunnion.Eds was performed on the debris in the v40 head and was consistent with material transfer from the accolade and biological material.No material or manufacturing defects were observed on the surfaces examined.-medical records received and evaluation: insufficient information was received for review with the clinical consultant.-device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other relevant events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.However no material or manufacturing defects were observed on the surfaces examined.Further information such as operative reports, xrays, patient history & follow-up notes are needed to investigate this event further.If additional information becomes available, this investigation will be reopened.

Event Description

It was reported that the patient had knee pain after twisting and was non weightbearing.Doctor took look at patient's current hip and noticed marks on femoral neck so decided to remove stem and liner.Both stem and liner were well fixed.

• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5205493
• MDR Text Key: 30546096
• Report Number: 0002249697-2015-03621
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/07/2015

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: 02/28/2013
• Device Catalogue Number: 6260-9-236
• Device Lot Number: 153MDE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2015
• Initial Date FDA Received: 11/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2008
• 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
• Patient Age: 54 YR