MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Catalog Number	625-0T-32E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	10/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Additional devices listed in this event: catalog: 6565-0-032, description: alumina v40-femoral head 32mm, -4mm, lot: 0705xira; catalog: 2030-6525-1, description: 6.5 cancellous bone screw 25mm, lot: 5eampd; catalog: 2030-6535-1, description: 6.5 cancellous bone screw 35mm, lot: 8a2med; catalog: 2060-0000-1, description: acetabular dome hole plug dome plug, lot: 308mpd; catalog: 502-01-54e, description: trident hemispherical cluster 54mm trident shell, lot: 23147801; catalog: 6020-0537, description: accolade tmzf hip stem #5 accolade stem, lot: 22826501.At this time, it cannot be determined which, if any of the reported devices may have caused or contributed to the patient's experience.Not returned to the manufacturer.
Event or Problem Description
Explantation of trident 0 degree alumina insert (alpha code e) and v40 alumina 32mm -4mm femoral head secondary to infection and subsequent mdm liner, x3 insert, 28mm ceramic head, and v40 universal adapter sleeve.

• Brand Name: TRIDENT ALUMINA INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8021502
• Report Number: 0002249697-2018-03552
• Device Sequence Number: 11061490
• Product Code: MRA
• UDI-Device Identifier: 04546540516848
• UDI-Public: 04546540516848
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/30/2018

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: 05/30/2012
• Device Catalogue Number: 625-0T-32E
• Device Lot Number: 22909902
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 10/30/2018
• 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: 74 YR