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 Corroded (1131); Material Separation (1562); Metal Shedding Debris (1804); Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Injury (2348); Joint Dislocation (2374); No Code Available (3191)

Event Date 12/22/2015

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

Patient presented in the er with a dislocated tha due to a disassociated head and was scheduled for surgery on (b)(6) 2015.During surgery there was significant metallosis notice in the joint.The trunnion of the accolade stem had black corrosion on it.The same was found in the disassociated femoral head.The surgeon decided to remove the stem, revise the femur and replace the liner.He used the restoration modular system for the femur revision.

Manufacturer Narrative

An event regarding alleged dissociation involving a v40 cocr lfit head 36mm/+5 was reported.The event was not confirmed.Method and results: device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined because the devices were not returned for evaluation and no medical information was provided.If the devices and/or additional information concerning disassociation are received, this investigation will be reopened and re-evaluated.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information becomes available, this investigation will be reopened.Note: it was reported that the trunnion of the accolade stem as well as the disassociated femoral head exhibited black corrosion.These devices were not returned to stryker orthopaedics.If the devices are received, this investigation will be reopened and the indications of corrosion will be investigated.

Event Description

Patient presented in the er with a dislocated tha due to a disassociated head and was scheduled for surgery on (b)(6) 2015.During surgery there was significant metallosis notice in the joint.The trunion of the accolade stem had black corrosion on it.The same was found in the disassociated femoral head.The surgeon decided to remove the stem, revise the femur and replace the liner.He used the restoration modular system for the femur revision.

• 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: 5378345
• MDR Text Key: 36344696
• Report Number: 0002249697-2016-00140
• 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: 12/22/2015

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: 09/30/2011
• Device Catalogue Number: 6260-9-236
• Device Lot Number: WXVMMA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2015
• Initial Date FDA Received: 01/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2006
• 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): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 110