MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 0580-1-442

Device Problems Degraded (1153); Material Deformation (2976)

Patient Problem Injury (2348)

Event Date 08/14/2019

Event Type  Injury  

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.

Event Description

The surgeon reported that he undertook a revision of a trident exeter hip.**update** the customer reported that the exeter trunnion was worn.The ceramic head was broken and the liner had wear marks.

Manufacturer Narrative

An event regarding wear involving an exeter stem was reported.The event was confirmed through visual inspection.Method & results: device evaluation and results: visual inspection: visual inspection was performed as part of the material evaluation and indicated the following comments: wear is observed on the stem trunnion.Observed damage is evidence of contact against mating component.Visual inspection was performed as part of the material analysis report (mar), dated 18- september-2019.This inspection indicated.-damage consistent with articulation against the alumina insert was observed on the stem trunnion.Damage consistent with impingement against the alumina liner/insert assembly was observed on the stem body and neck.Material analysis : a material analysis has been performed.The report concluded: based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: a review of the provided medical records by a clinical consultant indicated: 8/13/19 brief handwritten operative note.".Post.Approach.Metalosis lymph nodes and 100 ml graphite black.Excision/lavaged.Multiple ceramic head fragments/stem/ceramic liner removed.Cement mantle intact.New components inserted." no clinical or past medical history, no comprehensive operative reports, no x-rays, no examination of explanted components, and no surgical pathology reports.While the brief, handwritten revision operative note seems to partially confirm the event description, there is insufficient data to create a report for this event.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.

Event Description

The surgeon reported that he undertook a revision of a trident exeter hip.Update** the customer reported that the exeter trunnion was worn.The ceramic head was broken and the liner had wear marks.

• Brand Name: EXETER V40 STEM 44MM NO 2
• 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: 8997523
• MDR Text Key: 161574611
• Report Number: 0002249697-2019-03183
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 04546540153319
• UDI-Public: 04546540153319
• 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,other
• Type of Report: Initial,Followup
• Report Date: 11/20/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 0580-1-442
• Device Lot Number: G7270615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Initial Date Manufacturer Received: 08/16/2019
• Initial Date FDA Received: 09/11/2019
• Supplement Dates Manufacturer Received: 10/23/2019
• Supplement Dates FDA Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 140