MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0° X3 INSERT 32MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	623-00-32E
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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
It was reported that tha was done with trident ha shell and x3 liner and stem.The shell was dislocated in about one year after tha.Therefore, all devices were removed and revision surgery was done.The removed polyethylene liner was yellowish discolored.Update dec 17, 2018- cause of revision shell was dislocated (malposition).
Event or Problem Description
It was reported that tha was done with trident ha shell and x3 liner and stem.The shell was dislocated in about one year after tha.Therefore, all devices were removed and revision surgery was done.The removed polyethylene liner was yellowish discolored.Update dec 17, 2018- cause of revision shell was dislocated (malposition).
Additional Manufacturer Narrative
An event regarding loosening involving a trident shell was reported.Based on the provided information the product reported in this investigation did not contribute to the event.There is no allegation of failure against the device.The event reported that the shell had become loose from the acetabulum, the trident liner does not interface with bone.Visual inspection: the liner was returned locked into the shell.It presents with no scratches/indentations however there is some yellow discoloration in and around the head bearing surface- this is consistent with the absorption of synovial fluid by the device.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIDENT 0° X3 INSERT 32MM 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: 8204034
• Report Number: 0002249697-2018-04163
• Device Sequence Number: 13867200
• Product Code: LPH
• UDI-Device Identifier: 07613327039450
• UDI-Public: 07613327039450
• Combination Product (Y/N): N
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2019

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: 06/30/2022
• Device Catalogue Number: 623-00-32E
• Device Lot Number: 5V34PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 03/21/2019
• 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: 81 YR
• Patient Weight: 40