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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 03/25/2011

Event Type  Injury  

Manufacturer Narrative

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.Review of the device history records indicates that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.

Event Description

Per medical review: ¿on (b)(6) 2011 a closed reduction and manipulation under anesthesia for a dislocated left total hip was performed.It was noted post-reduction to be unstable in adduction and internal rotation¿.

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) 2009 the left total hip arthroplasty dislocated and she had a manipulation under anesthesia performed to relocate it.¿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) 2009 the left total hip arthroplasty dislocated and she had a manipulation under anesthesia performed to relocate it.¿ the patient also had a second dislocation closed reduction on (b)(6) 2011 and an actual revision surgery for dislocation on (b)(6) 2012.

Event Description

Per medical review: ¿on (b)(6) 2011 a closed reduction and manipulation under anesthesia for a dislocated left total hip was performed.It was noted post-reduction to be unstable in adduction and internal rotation.¿.

• Brand Name: TRIDENT ALUMINA INSERT
• Type of Device: 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: 7856305
• MDR Text Key: 119556722
• Report Number: 0002249697-2018-02797
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 04546540516848
• UDI-Public: 04546540516848
• Combination Product (y/n): N
• PMA/PMN Number: P000013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2009
• Device Catalogue Number: 625-0T-32E
• Device Lot Number: 9803702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 66