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

Catalog Number 6260-5-032

Device Problems Degraded (1153); Material Fragmentation (1261); Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Date 06/12/2020

Event Type  Injury  

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.Device not returned.

Event Description

It was reported that a revision hip was performed due to the cup spinning out and that the surgeon noticed black debris on trunnion and femoral head when head removed from stem.It was further reported that this procedure involved a trident cup x3, 0 degree liner, accolade 2 stem, 32 -4 head.

Manufacturer Narrative

Reported event: an event regarding wear involving a metal head was reported.The event was confirmed through material analysis evaluation of the returned device.Method & results: -device evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 17 september 2020.This inspection indicated: wear damage on the inner taper of the head was consistent with interaction against the stem trunnion.A material analysis has been performed.The report concluded: the sem analysis on the head taper was consistent with fretting wear.Eds showed that the head alloy was consistent with the material call out on the drawing (an astm f1537 alloy).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 or the product is returned, this investigation will be re-opened.

Event Description

It was reported that a revision hip was performed due to the cup spinning out and that the surgeon noticed black debris on trunnion and femoral head when head removed from stem.It was further reported that this procedure involved a trident cup x3, 0 degree liner, accolade 2 stem, 32 -4 head.

• Brand Name: 32MM -4 V40 TAPER VIT HEAD
• 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: 10212219
• MDR Text Key: 197304515
• Report Number: 0002249697-2020-01350
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K173499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 6260-5-032
• Device Lot Number: 51561803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Manufacturer Received: 06/12/2020
• Initial Date FDA Received: 06/30/2020
• Supplement Dates Manufacturer Received: 09/23/2020
• Supplement Dates FDA Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 54