MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA V40-FEMORAL HEAD 36MM, +0MM NK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6565-0-136
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/14/2019
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.
Event or Problem 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.
Event or Problem Description
The surgeon reported that he undertook a revision of a trident exeter hip.The customer reported that the exeter trunnion was worn.The ceramic head was broken and the liner had wear marks.
Additional Manufacturer Narrative
An event regarding crack/fracture involving an alumina femoral head was reported.The event was confirmed upon visual inspection of the device.Method & results: device evaluation and results: visual inspection was performed as part of the material evaluation and indicated the following comments: the device was returned in four separate fragments, confirming fracture described in event details.Material analysis was performed.Visual inspection was performed as part of the material analysis report (mar), dated 18- september-2019.This inspection indicated approximately 70% of the ceramic head was returned.Metal transfer markings and secondary chipping were observed on the head fragments the fracture surfaces were obscured by post-fracture chipping.A material analysis has been performed.The report concluded: the returned ceramic head had fractured.The head likely fractured due to hoop stresses caused by the wedge effect.A continuous metal transfer ring was not observed at the proximal end of the head taper.Damage was observed on the insert and head fragments consistent with articulating against each other after the head fractured.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 and/or x-rays by a clinical consultant indicated: 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.

• Brand Name: ALUMINA V40-FEMORAL HEAD 36MM, +0MM NK
• 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: 8997526
• Report Number: 0002249697-2019-03182
• Device Sequence Number: 16866805
• Product Code: JDI
• UDI-Device Identifier: 04546540390486
• UDI-Public: 04546540390486
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 6565-0-136
• Device Lot Number: 62347103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 11/20/2019
• 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: 62 YR
• Patient Weight: 140