MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG INSERT 40MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	623-00-40E
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	09/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: tridentii tritanium cluster52e; cat# 702-04-52e; lot# 59319501 uni adaptor sleeve v40 ti; cat# 6519-t-100; lot# 58782502 delta un.Fem hd 40mm r40 16/18; cat# 6519-1-040; lot# 58944302.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Review of the device history records indicate the devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.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.Not available.
Event or Problem Description
Physician revised a cup, liner and head/sleeve of a left hip due to infection.
Additional Manufacturer Narrative
Additional information: product available to stryker.An event regarding infection involving a trident liner, trident shell, hip sleeve and ceramic head was reported.The event was not confirmed.A trident liner was returned inside a trident shell.There was no evidence of damage to the device.Refer to images of returned devices.Dimensional inspection: not performed as the failure mode is not related to the dimensional properties of the device.Functional inspection: not performed as it is not possible to replicate the failure mode of infection.Material analysis: not performed as the failure mode is not related to material integrity.No medical records were received for review with a clinical consultant.All devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no similar events for the reported lot or sterile lot.The exact cause of the event could not be determined because insufficient information was received.Further information such as pathology reports, x-rays, operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.If additional information becomes available, this investigation will be reopened.
Event or Problem Description
Physician revised a cup, liner and head/sleeve of a left hip due to infection.

• Brand Name: TRIDENT 0 DEG INSERT 40MM
• 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: 6973591
• Report Number: 0002249697-2017-03090
• Device Sequence Number: 10901674
• Product Code: LPH
• UDI-Device Identifier: 07613327025323
• UDI-Public: 07613327025323
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K062419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2018

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: 04/17/2022
• Device Catalogue Number: 623-00-40E
• Device Lot Number: DV865J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Initial Date Received by Manufacturer: 09/26/2017
• Supplement Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 01/10/2018
• 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: 61 YR