MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0° CROSSFIRE INSERT 36 MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	621-00-36F
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348); Reaction (2414)
Date of Event	09/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer however, explant photos show wear.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
Event or Problem Description
Head disassociation revision, trunionosis, infected hip with placement of stem and all poly cup.(b)(6) 2018: explant photos show trunnion damage and poly wear.
Additional Manufacturer Narrative
An event regarding infection and wear/damage of a trident liner was reported.The infection could not be confirmed, however, wear/damage could be confirmed based on the photograph of the explanted devices.Methods and results: device evaluation and results: the reported device was not returned however photographs were provided for review.The photographs show an image of the stem in-situ and also an image of the recently explanted stem, head and liner.Blood and tissue are visible on the recently explanted components.The trunnion of the stem which locks into the mating head has worn to a point.The liner is severely worn and damaged.From the images provided, no visible issues can be identified on the explanted head.Medical records received and evaluation: 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 or sterile lot conclusion based on the provided information wear/damage of the liner is confirmed- the photographs show an image of the stem in-situ and also an image of the recently explanted stem, head and liner.Blood and tissue are visible on the recently explanted components.The trunnion of the stem which locks into the mating head has worn to a point.The liner is severely worn and damaged.From the images provided, no visible issues can be identified on the explanted head.Infection cannot be confirmed and the exact cause of the wear event could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes, x-rays, pathology reports indicating the strain of infection and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Head disassociation revision, trunionosis, infected hip with placement of stem and all poly cup.(b)(6) 2018: explant photos show trunnion damage and poly wear.

• Brand Name: TRIDENT 0° CROSSFIRE INSERT 36 MM ID
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8054634
• Report Number: 0002249697-2018-03667
• Device Sequence Number: 19341689
• Product Code: LPH
• UDI-Device Identifier: 07613327023756
• UDI-Public: 07613327023756
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K021911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2018

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: 11/30/2014
• Device Catalogue Number: 621-00-36F
• Device Lot Number: MHR2N0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/11/2018
• Supplement Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 11/09/2018
• Supplement Report FDA Received Date: 12/18/2018
• 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: 73 YR
• Patient Weight: 108