MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNC

Catalog Number	625-0T-32E
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	04/01/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other 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.
Event or Problem Description
Per medical review: ¿on (b)(6) 2012 she was seen follow-up for left total hip revision for recurrent dislocation performed in (b)(6) of 2011 and was noted to be "doing very well, not much in the way of pain and hip stable, return one year".
Event or Problem Description
Per medical review: ¿on (b)(6) 2012 she was seen follow-up for left total hip revision for recurrent dislocation performed in (b)(6) 2011 and was noted to be "doing very well, not much in the way of pain and hip stable, return one year".
Additional Manufacturer Narrative
An event regarding dislocation closed reduction involving a trident liner was reported.The event was confirmed by medical review.Method & results: product evaluation and results: visual, dimensional, functional inspection, and material analysis were not performed as the item was not returned.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: ¿on (b)(6) 2012 she was seen follow-up for left total hip revision for recurrent dislocation performed in (b)(6) 2011 and was noted to be "doing very well, not much in the way of pain and hip stable, return one year".¿the apparent failure of biologic fixation of the proximal femoral component in this osteoporotic bone and the stress riser at the proximal end of the well-fixed long lateral plate, which coincided with the junction of the distal fixed and proximal loose stem, resulted in cyclic loading at the site of fracture.As the proximal stem cycled into varus the fracture was initiated laterally and progressed to completion.Given the mechanical situation, fracture was inevitable.¿ ¿review of this additional information confirms the conclusions of my earlier report.The stem fractured at the junction of the proximal loose portion where it met the distally fixed portion resulting in cyclic loading in varus subsequently leading to fatigue failure initiated at the lateral side.This was confirmed by the previously reviewed material analysis report of (b)(6) 2010, which also noted, "no material or manufacturing defects were observed." product history review: review of the product history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: the reported event for dislocation closed reduction was confirmed by the medical review which stated, ¿on (b)(6) 2012 she was seen follow-up for left total hip revision for recurrent dislocation performed in (b)(6) 2011 and was noted to be "doing very well, not much in the way of pain and hip stable, return one year".The patient also suffered two dislocation closed reductions prior to this revision surgery.

• Brand Name: TRIDENT ALUMINA INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7857026
• Report Number: 0002249697-2018-02798
• Device Sequence Number: 1986737
• Product Code: MRA
• UDI-Device Identifier: 04546540516848
• UDI-Public: 04546540516848
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: P000013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2018

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: 06/30/2009
• Device Catalogue Number: 625-0T-32E
• Device Lot Number: 9803702
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 09/07/2018
• Supplement Report FDA Received Date: 12/26/2018
• 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
• Patient Age: 51 YR
• Patient Weight: 66