MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/+10; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 6260-9-336

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994); Reaction (2414)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate the devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

Patient called to report extreme pain in her right hip replacement.She is also experiencing pain in her left groin.Her doctor alleges that she has cobalt and chromium in her system.She had her surgery on (b)(6) 2012.She started experiencing the pain approximately (b)(6) 2017.

Manufacturer Narrative

An event regarding pain and abnormal ion levels involving a metal head was reported.The event was confirmed.An event regarding pain and abnormal ion levels involving a metal head was reported.The event was confirmed.Device evaluation and results: visual, dimensional and functional inspection were not performed as the item was not returned.Medical records received and evaluation: the provided medical information was submitted to a consulting clinician who indicated: "the primary harm involved is pain.A review of intra-operative, immediate post- operative an two year follow-up xrays show the tha implants to be in proper position.They are appear well fixed within the bone with pristine bone prosthetic interfaces.There is no radiographic evidence of material wear.No evidence to support metal ion disease was presented.There is no evidence for defect in the implants or their manufacture." the provided additional medical information was submitted to a consulting clinician who indicated that" the primary harm involved is reported to be pain.Patient has objective findings consistent with metallosis including mri and elevated serum levels.Definitive root causation may be determined at time of revision hip surgery through operative inspection, surgical pathology and implant retrieval followed my material analysis." review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there has been no other event for this lot.It was reported that patient is experiencing pain & her doctor alleges that she has cobalt and chromium in her system.The event was confirmed on the basis of medical addendum.The provided medical information was submitted to a consulting clinician who concluded that the primary harm involved is reported to be pain.Patient has objective findings consistent with metallosis including mri and elevated serum levels.Definitive root causation may be determined at time of revision hip surgery through operative inspection, surgical pathology and implant retrieval followed my material analysis.Furthermore, as per product recall verification response it is confirmed that none of the reported devices were part of the recall.If devices and/or additional information become available, this investigation will be reopened.

Event Description

Patient called to report extreme pain in her right hip replacement.She is also experiencing pain in her left groin.Her doctor alleges that she has cobalt and chromium in her system.She had her surgery on (b)(6) 2012.She started experiencing the pain approximately (b)(6) 2017.

• Brand Name: V40 COCR LFIT HEAD 36MM/+10
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• 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: 6806904
• MDR Text Key: 83119192
• Report Number: 0002249697-2017-02556
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053528
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2015
• Device Catalogue Number: 6260-9-336
• Device Lot Number: MJE8HE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2010
• 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): Other
• Patient Age: 60 YR
• Patient Weight: 66