MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10 X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	623-10-36E
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/01/2010
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.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.
Event or Problem Description
It has been reported "an email has been received from a medical examiner commissioned by a private health facility to prepare a medical-legal opinion on a painful hip post prosthesis with trident psl acetabulum.Ha, trident x3 polyethylene insert and lfit anatomic femoral head.The placement of the prosthesis took place in (b)(6) 2010; in (b)(6) 2013 the prosthesis was subjected to revision with replacement of the acetabulum and the insert that had debris.In the operating report, among other things, reported: arthrotomy.Abundant "sawdust" material is found surrounding the cup and affecting the femoral epiphysis.It is carefully removed and abundantly washed.This material is due to the debris of the acetabular polyethylene, therefore it is removed.The radiological assessments from 2010 to 2013 did not highlight any loosening of the prosthesis or implant defects".

• Brand Name: TRIDENT 10 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: 11607118
• Report Number: 0002249697-2021-00598
• Device Sequence Number: 4009399
• Product Code: LPH
• UDI-Device Identifier: 07613327039917
• UDI-Public: 07613327039917
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2021

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: 11/30/2014
• Device Model Number: 623-10-36E
• Device Catalogue Number: 623-10-36E
• Device Lot Number: 31804601
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 04/02/2021
• 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