MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +4 V40 TAPER VIT HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-5-232
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	07/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not available.
Event or Problem Description
It was reported that patient presented with pain in right hip at the emergency department.The patient reported the pain started approximately one year ago.It was further reported that a subsequent x-ray showed head dissociated from stem.Patient required revision hip surgery to remove hip stem.
Event or Problem Description
It was reported that patient presented with pain in right hip at the emergency department.The patient reported the pain started approximately one year ago.It was further reported that a subsequent x-ray showed head dissociated from stem.Patient required revision hip surgery to remove hip stem.
Additional Manufacturer Narrative
An event regarding disassociation involving a metal head was reported.The event was confirmed through mar.Method & results: device evaluation and results: visual inspection: visual inspection was performed as part of the material analysis report (mar), dated (b)(6) 2019.This inspection indicated: scratching consistent with contact against a hard object was observed on the articulating surface of the head.Damage present on the surface of the taper is consistent with interaction between the head and trunnion.Dimensional & functional inspection: not performed as the reported device was implanted and subsequently explanted.The device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Material analysis a material analysis has been performed.The report concluded: damage was observed on the stem neck and trunnion consistent with the loss of taper lock.The damage present on the articulating surface of the insert is consistent with burnishing, scratching and third body indentations; which are common damage modes of uhmwpe.Material deformation of the insert consistent with impingement against the stem was also observed.The yellow discoloration on the liner is consistent with absorption of synovial fluid.Xrf showed the stem and head were consistent with an astm f1813 alloy and an astm f1537 alloy, respectively.The debris collected form the trunnion is consistent with a corrosion product, an oxide, and biological material.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all devices 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.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes and x-rays are needed to fully investigate the event.If further information becomes available this investigation will be re-opened.

• Brand Name: 32MM +4 V40 TAPER VIT HEAD
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8873362
• Report Number: 0002249697-2019-02772
• Device Sequence Number: 2390055
• Product Code: JDI
• UDI-Device Identifier: 07613327012903
• UDI-Public: 07613327012903
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: 6260-5-232
• Device Lot Number: 37137307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: 07/13/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR