MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA SOLID BACK 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	540-11-50E
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Osteolysis (2377); Inadequate Osseointegration (2646)
Date of Event	05/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection: not performed as the device was not returned.Dimensional inspection not performed as the device was not returned.Functional inspection: not performed as the device was not returned.Material analysis: not performed as the device was not returned.Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported relevant discrepancies.There have been no other similar events for the lot referenced.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that patients' right hip was revised due to pain, osteolysis, and aseptic loosening.Intra-operatively, surgeon reported that patient had an acetabular discontinuity due to a healed fracture (rep reported that no plates or screws had been used to address the fracture).Patient was revised to competitor shell and liner with a stryker universal taper biolox head.

• Brand Name: TRIDENT PSL HA SOLID BACK 50MM
• 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: 7602932
• Report Number: 0002249697-2018-01816
• Device Sequence Number: 11111807
• Product Code: LPH
• UDI-Device Identifier: 04546540237828
• UDI-Public: 04546540237828
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2018

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: 09/30/2008
• Device Catalogue Number: 540-11-50E
• Device Lot Number: 96030301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2018
• Initial Report FDA Received Date: 06/14/2018
• 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
• Patient Weight: 87