MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° CROSSFIRE INSERT 28 MM ID; HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES

Catalog Number	621-10-28G
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Fall (1848); Injury (2348)
Date of Event	09/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding crack/fracture involving a exeter stem was reported.Material analysis of the returned device confirmed impingement (rom) between the stem and trident liner.Method & results: product evaluation and results: visual inspection was performed as part of the material analysis report and noted the following: the proximal and articulating surfaces of the insert are shown in figures 10 and 11, respectively.Damage was observed at multiple locations on the distal rim of the insert, consistent with contact against the stem and the explantation process.A detailed image of the articulating surface of the insert is shown, with burnishing, scratching and third-body indentations being observed.These are common damage modes of uhmwpe.Material analysis: the mar concluded the following: damage consistent with impingement was observed on the distal rim of the insert.Additionally, burnishing, scratching and third-body indentations were observed on insert.These are common damage modes of uhmwpe.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: not performed as no medical records were returned for review.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there were no other events for the lot provided.Conclusions: the mar concluded: damage consistent with impingement was observed on the distal rim of the insert.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Patient presented with a broken exeter on xray following a fall.The exeter stem and trident liner was removed and replaced with a long stem exeter.Update 19 december, 2018: mar confirmed that stem fractured in fatigue and also noted evidence of impingement between stem and liner and iron oxide debris on the stem.

• Brand Name: TRIDENT 10° CROSSFIRE INSERT 28 MM ID
• Common Device Name: HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8253147
• Report Number: 0002249697-2019-00207
• Device Sequence Number: 16675373
• Product Code: LPH
• UDI-Device Identifier: 07613327037760
• UDI-Public: 07613327037760
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K983502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/16/2019

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: 08/30/2007
• Device Catalogue Number: 621-10-28G
• Device Lot Number: 04258201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 01/16/2019
• 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: 81 YR
• Patient Weight: 95