MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0° X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	623-00-36H
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Joint Dislocation (2374)
Date of Event	07/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There was another event for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Patient called stating he had a left hip implant on (b)(6) 2005.Patient noted that 2 months ago as he got up from using the bathroom he noticed pain.Patient stated his pelvis and femur disconnected.Patient underwent revision surgery on (b)(6) 2018 to stryker devices.
Additional Manufacturer Narrative
An event regarding disassociation of a femoral head from the stem trunnion involving a trident liner was reported.Conclusions: it was reported that the patient stated that his pelvis and femur disconnected.Material analysis of the returned devices noted that damage was observed on the stem trunnion and head taper.This damage was consistent with wear mechanisms due to the cyclic contact between the head taper and stem trunnion after the loss of their taper lock.Debris was also observed on the stem trunnion.Eds showed the stem was consistent with astm f1813 alloy, the head was consistent with astm f1537 alloy, the cable was consistent with astm f90 alloy and the debris was consistent with a corrosion product, stem base alloy and biological material.Scratching was observed on the insert, which is a common damage mode of uhmwpe.Yellow discoloration consistent with absorption of synovial fluid was also observed on the insert.Based on the provided information the product reported in this investigation did not contribute to the event.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.
Event or Problem Description
Patient called stating he had a left hip implant on (b)(6) 2005.Patient noted that 2 months ago as he got up from using the bathroom he noticed pain.Patient stated his pelvis and femur disconnected.Patient underwent revision surgery on (b)(6) 2018 to stryker devices.

• Brand Name: TRIDENT 0° X3 INSERT 36MM ID
• 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: 7984813
• Report Number: 0002249697-2018-03442
• Device Sequence Number: 1395816
• Product Code: LPH
• UDI-Device Identifier: 07613327039559
• UDI-Public: 07613327039559
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2019

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: 04/30/2010
• Device Catalogue Number: 623-00-36H
• Device Lot Number: 27609601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 02/22/2019
• 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: 76 YR
• Patient Weight: 145