MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/-5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 6260-9-036

Device Problems Device Contamination with Chemical or Other Material (2944); Naturally Worn (2988); Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Date 05/05/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested and if received, will be provided in the supplemental report.

Event Description

Sus voluntary event report #mw 5060826: replacement of hip implant on 2016.Patient was experiencing pain after initial arthroplasty.Required surgical removal of implant.During removal, surgeon noted wear seen at trunnion with blackend material seen after knocking the head off the trunnion.

Manufacturer Narrative

An event regarding corrosion involving a metal head was reported.The event was not confirmed.Method & results: device evaluation could not be performed as the subject device was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.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 the devices were not returned for evaluation and insufficient medical information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Sus voluntary event report #mw 5060826: replacement of hip implant on 2016.Patient was experiencing pain after initial arthroplasty.Required surgical removal of implant.During removal, surgeon noted wear seen at trunnion with blackend material seen after knocking the head off the trunnion.

Manufacturer Narrative

It was determined that this event is a duplicate of mfr.Report#: 0002249697-2017-00936.Investigations and conclusions will be documented under this manufacturer report number.

Event Description

Sus voluntary event report #mw 5060826: replacement of hip implant on 2016.Patient was experiencing pain after initial arthroplasty.Required surgical removal of implant.During removal, surgeon noted wear seen at trunnion with blackend material seen after knocking the head off the 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
• MDR Report Key: 5652383
• MDR Text Key: 45119216
• Report Number: 0002249697-2016-01588
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K022077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 6260-9-036
• Device Lot Number: MMPMY9
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention