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 Material Deformation (2976); Material Integrity Problem (2978)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 03/17/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Revision hip left side.Deformation of the femoral trunnion.

Manufacturer Narrative

An event regarding "deformation of the femoral trunnion" was reported.The event was confirmed.Method and results: device evaluation and results: visual inspection was performed as part of the material analysis report (mar).Damage was also observed on the taper of the head, likely from interacting with the trunnion of the accolade stem." a material analysis was performed and concluded: "no material or manufacturing defects were observed on the surfaces examined" medical records received and evaluation: a medical review was performed and concluded: "cup malposition in slightly superficial position with protruding cup rim in joint space together with use of a 10° liner in a cup shell with already normal cup position have promoted impingement causing overload in the trunnion ultimately ending in catastrophic trunnion failure with disassociation of the femoral head requiring revision" 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: a medical review was performed and determined that cause of the trunnion failure related to malposition of the shell.There was no evidence of a device related issue.Further to this a material analysis was performed and concluded that "no material or manufacturing defects were observed on the surfaces examined." no further investigation is required at this time.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

Revision hip left side.Deformation of the femoral trunnion.

• 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 colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5567391
• MDR Text Key: 42384145
• Report Number: 0002249697-2016-01185
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/17/2016

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: 10/31/2011
• Device Catalogue Number: 6260-9-236
• Device Lot Number: RJRMNA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/17/2016
• Initial Date FDA Received: 04/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2006
• 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): Required Intervention
• Patient Age: 79 YR