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

Catalog Number	623-00-40G
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	08/06/2019
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.
Event or Problem Description
Patient had a few dislocations and doctor was able to close reduce it without informing the rep.Physician decided to change to dual mobility for better stability.
Additional Manufacturer Narrative
Additional information: update to lot number.An event regarding dislocation involving a trident liner was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection: visual inspection was performed as part of the material evaluation and indicated the following comments: damage consistent with the implantation/explantation process was observed on the distal rim, proximal rim and proximal surface.Burnishing, scratching and third body indentations were observed on the articulating surface which are common damage modes of uhmwpe.No materials or manufacturing discrepancies were observed on the surfaces examined.Dimensional inspection: not performed as the dimensional aspects are not in question.Functional inspection: not performed as the functional aspects are not in question.Material analysis material evaluation was completed and indicated the following comments: ma: damage consistent with the implantation/explantation process was observed on the distal rim, proximal rim and proximal surface.Burnishing, scratching and third body indentations were observed on the articulating surface which are common damage modes of uhmwpe.No materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: not performed as no medical records were returned for review.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there were no other events for the lot provided.Conclusions: the exact cause of the event could not be determined because insufficient information.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and /or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Patient had a few dislocations and doctor was able to close reduce it without informing the rep.Physician decided to change to dual mobility for better stability.

• 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: 8955407
• Report Number: 0002249697-2019-03044
• Device Sequence Number: 13977975
• Product Code: LPH
• UDI-Device Identifier: 07613327025361
• UDI-Public: 07613327025361
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K061434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2019

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: 11/30/2020
• Device Catalogue Number: 623-00-40G
• Device Lot Number: MD3ART
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 11/07/2019
• 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