MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 FEM HEAD ORTHINOX 28-4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6364-2-028
Medical Device Problem Codes	Degraded (1153); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Inflammation (1932); Pain (1994); Injury (2348); Reaction (2414); Ambulation or Postural Difficulties (2544)
Date of Event	07/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.
Event or Problem Description
Patient presented complaining about pain in femur sometime after a fall , so x rays were taken and it appeared to have ¿void bubbles¿ akin to lysis/infection/ metallosis etc around the implant and cement mantle so the surgeon decided to revise it.The results from the 2x specimens taken from the hip capsule during the revision procedure: one had no sign of abnormality however the other showed ¿clusters of poly morph in black metallosis¿.Dr (b)(6) decided to do a 1st stage revision with a ¿kiwi spacer¿.Thr done approximately 15 years ago (with exeter/ trident thr).Left side.
Additional Manufacturer Narrative
Reported event: an event regarding fretting involving a metal head which mated with an exeter stem was reported.The event was confirmed through material analysis of the returned product.Method & results: device evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 10 december 2019.This inspection indicated: the stem and head were returned in the assembled condition.Debris was observed on the head.A material analysis has been performed.The report concluded: the damage present on the articulating surface of the insert was consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.The yellow discoloration on the insert was consistent with absorption of synovial fluid.The damage present on the stem was consistent with the cement mantle breakdown process and the collected debris was consistent with an oxide, corrosion product, and biological material.The base material of stem and head were consistent with their drawings.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: need operative reports, office/clinical reports, serial x-rays, and examination of the explanted components.Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: visual inspection was performed as part of the material analysis report (mar), dated 10 december 2019.This inspection indicated: the stem and head were returned in the assembled condition.Debris was observed on the head.A material analysis has been performed.The report concluded: the damage present on the articulating surface of the insert was consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.The yellow discoloration on the insert was consistent with absorption of synovial fluid.The damage present on the stem was consistent with the cement mantle breakdown process and the collected debris was consistent with an oxide, corrosion product, and biological material.The exact cause of the event cannot be confirmed as insufficient information was provided.Further information such as operative reports, office/clinical reports, serial x-rays, and examination of the explanted components are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Patient presented complaining about pain in femur sometime after a fall , so x rays were taken and it appeared to have ¿void bubbles¿ akin to lysis/infection/ metalosis etc around the implant and cement mantle so the surgeon decided to revise it.The results from the 2x specimens taken from the hip capsule during the revision procedure: one had no sign of abnormality however the other showed ¿clusters of poly morph in black metalosis¿.Dr lane decided to do a 1st stage revision with a ¿kiwi spacer¿.Thr done approximately 15 years ago (with exeter/ trident thr).Left side.

• Brand Name: V40 FEM HEAD ORTHINOX 28-4
• 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: 8866551
• Report Number: 0002249697-2019-02757
• Device Sequence Number: 2824292
• Product Code: JDI
• UDI-Device Identifier: 04546540273277
• UDI-Public: 04546540273277
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• 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): 01/10/2020

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: 03/31/2009
• Device Catalogue Number: 6364-2-028
• Device Lot Number: GC932121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 01/10/2020
• 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