MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG X3 INSERT 32MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	623-00-32C
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	08/05/2018
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.The following devices were also listed in this report: trident hemispherical multi; cat# 508-11-46c; lot# 63553201, size 2 accolade ii 127 deg; cat# 6721-0230; lot# 54053902, delta v-40 ceramic head 32/+4; cat# 6570-0-232; lot# 63020204, 6.5 cancellous bone screw 16mm; cat# 2030-6516-1; lot# a73dhn, 6.5 cancellous bone screw 20mm; cat# 2030-6520-1; lot# vr0x4d.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
Primary surgery against osteoarthritis with trident, accolade and delta ceramic head was performed on (b)(6) 2018.Then, removal surgery was performed and mold type cement spacer was implanted on (b)(6) 2018 due to infection of implanted site.Lesion: left hip.

• Brand Name: TRIDENT 0 DEG X3 INSERT 32MM 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: 7908409
• Report Number: 0002249697-2018-03034
• Device Sequence Number: 19238710
• Product Code: LPH
• UDI-Device Identifier: 07613327025354
• UDI-Public: 07613327025354
• Combination Product (Y/N): N
• PMA/510(K) Number: K062419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2018

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: 12/31/2022
• Device Catalogue Number: 623-00-32C
• Device Lot Number: RX2TP1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/25/2018
• 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