MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL CLUSTER 64MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	502-01-64H
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Injury (2348); Osteolysis (2377)
Date of Event	11/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.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.
Event or Problem Description
As reported: "loose components with severe osteolysis.Replaced with 64mm tritanium multihole cup with 4 screws 2x20, 2x25, 36mm e 0° liner, restoration modular 21 x 155 stem x 20 body, 36 +5 biolox head.Routine revision tha".The shell and stem were reported loose.Nothing regarding the screws was reported.It was confirmed that this was a revision of the primary, clarified lot number on stem.

• Brand Name: TRIDENT HEMISPHERICAL CLUSTER 64MM
• 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: 8157519
• Report Number: 0002249697-2018-04010
• Device Sequence Number: 2261426
• Product Code: LPH
• UDI-Device Identifier: 07613153073147
• UDI-Public: 07613153073147
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/12/2018

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: 04/30/2012
• Device Catalogue Number: 502-01-64H
• Device Lot Number: 26427701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 12/12/2018
• 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