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

Catalog Number	623-00-40F
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	08/16/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding dislocation involving a trident liner was reported.Conclusion: based on the provided information it has been determined that this event is associated with an off-label application.It was reported that a trident shell and liner were implanted with a competitor¿s head.It was then reported this mixed component system dislocated.The reported liner is packaged with instructions for use (qin 4350, rev c) that states, ¿warnings: do not substitute another manufacturer¿s device for any of the howmedica osteonics trident system components because design, material, or tolerance differences may lead to premature device and/or functional failure.Components of the system have been specifically designed to work together.Any such use will negate the responsibility of howmedica osteonics corp.For the performance of the resulting mixed component implant.¿ no further investigation is required at this time.Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Not available.
Event or Problem Description
On (b)(6) 2011 it was noted patient fell in the bathroom and x-ray revealed a posterior dislocation that was treated with closed reduction under sedation in the emergency room.The stem and head are competitor products.
Additional Manufacturer Narrative
This record is a duplicate of 0002249697-2016-03339.Therefore, this record will be cancelled.
Event or Problem Description
On august 16, 2011 it was noted patient fell in the bathroom and x-ray revealed a posterior dislocation that was treated with closed reduction under sedation in the emergency room.The stem and head are competitor products.

• 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: 7919128
• Report Number: 0002249697-2018-03124
• Device Sequence Number: 19169247
• Product Code: LPH
• UDI-Device Identifier: 07613327025316
• UDI-Public: 07613327025316
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K061434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2018

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: 05/31/2015
• Device Catalogue Number: 623-00-40F
• Device Lot Number: MJHPK1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/31/2018
• Supplement Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 10/08/2018
• 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: 78 YR
• Patient Weight: 101