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

Catalog Number	623-10-36G
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	11/08/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no similar events for the lot referenced.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.The following devices were also listed in this report: trident psl with purefix ha 60mm; 542-11-60g; 47585401, exeter v40 stem 44mm no 4; 0580-1-444; g3983796, alumina v40-femoral head 36mm, +5mm nk; 6565-0-236; 17274201, 6.5 cancellous bone screw 40mm; 2030-6540-1; mnd38x, 6.5 cancellous bone screw 35mm; 2030-6535-1; mnh6a9, 6.5 cancellous bone screw 16mm; 2030-6516-1; mmt2wk acetabular dome hole plug; 2060-0000-1; mmj405.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Not returned.
Event or Problem Description
The solicitor's letter indicated that the patient was implanted with a stryker right thr following revision surgery on (b)(6) 2014.On (b)(6), the patient was reviewed and mri scan showed chronic infection around the right hip replacement suggesting deep infection.The patient underwent first stage revision surgery on (b)(6) 2015.The patient remained without a hip joint while he was treated with antibiotics for 6 weeks.The patient underwent second stage (thr) surgery in 2016.
Additional Manufacturer Narrative
An event regarding infection involving a trident liner was reported.The event was not confirmed.Method & results: device evaluation and results: the device was not returned for analysis.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the reported lot and the reported sterile lot.Conclusions: the event and exact cause of the event could not be determined based on the information received.Further information such as device return, pathology reports, operative reports and x-rays are needed to complete the investigation for determining root cause.If additional information and/or the device become available, this investigation will be reopened.
Event or Problem Description
The solicitor's letter indicated that the patient was implanted with a stryker right thr following revision surgery on (b)(6) 2014.On (b)(6), the patient was reviewed and mri scan showed chronic infection around the right hip replacement suggesting deep infection.The patient underwent first stage revision surgery on (b)(6) 2015.The patient remained without a hip joint while he was treated with antibiotics for 6 weeks.The patient underwent second stage (thr) surgery in 2016.

• 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: 7324379
• Report Number: 0002249697-2018-00670
• Device Sequence Number: 10800993
• Product Code: LPH
• UDI-Device Identifier: 07613327039931
• UDI-Public: 07613327039931
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2018

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: 06/30/2019
• Device Catalogue Number: 623-10-36G
• Device Lot Number: 48425101
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2018
• Supplement Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 03/08/2018
• Supplement Report FDA Received Date: 04/09/2018
• 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