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); Nonstandard Device (1420); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/14/2016

Event Type  Injury  

Manufacturer Narrative

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

Implants have been removed from a patient undergoing revision total hip surgery.The surgeon would like the prosthesis to be examined to ensure they are ok.Patient had a pseudo tumour and signs of trunnionosis.Surgeon was not sure as to why the patient had this symptom and wanted to exclude prosthesis abnormality.

Manufacturer Narrative

Additional information: product available to stryker; returned to manufacturer on.An event regarding damage and corrosion involving a v40 cocr lfit head 36 mm/+5 that was mated with an accolade stem was reported.The event was confirmed.Method & results: -device evaluation and results: material analysis has been performed and indicated "burnishing, scratching and third-body indentations were observed on the insert.These are common damage modes of uhmwpe.Evidence of impingement was observed on the distal rim of the insert.Discoloration was observed on the taper of the head.Eds showed the head was consistent with astm f1537 alloy, and the discoloration was consistent with a corrosion process, material transfer from a hip stem and biological material.No material or manufacturing defects were observed on the surfaces examined." -medical records received and evaluation: the medical records were reviewed by the consulting clinician and indicated "the primary harm involved is a presumed adverse reaction to metallic debris from a tha.No clinical information was available for review.Detailed material analysis was performed on the explanted femoral head and acetabular uhmwp acetabular liner tha components.Analysis on the femoral stem and trunnion were not performed.It is not known of these were explanted at the time of revision surgery.Documentation which would aid int he further completion of this assessment would include operative reports, surgical implant records, pre and post op x-rays from the index and revision surgeries, laboratory reports including serum cobalt, chromium and titanium levels, surgical pathology reports, outpatient office/clinic notes and the return of the femoral stem if explanted." -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: the subject device has been identified to be within scope of ra 2016-028.Lot specific voluntary recall ra 2016-028 was initiated for the lfit v40 cocr heads.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before march 4, 2011.The root cause analysis identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.No further investigation is required.

Event Description

Implants have been removed from a patient undergoing revision total hip surgery.The surgeon would like the prosthesis to be examined to ensure they are ok.Patient had a pseudo tumour and signs of trunnionosis.Surgeon was not sure as to why the patient had this symptom and wanted to exclude prosthesis abnormality.

• 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: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6240997
• MDR Text Key: 64484828
• Report Number: 0002249697-2017-00166
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/29/2017

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: 10/31/2014
• Device Catalogue Number: 6260-9-236
• Device Lot Number: MHNJJ9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2016
• Initial Date FDA Received: 01/11/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2249697-08/29/2016-007R
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 90