MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG INSERT 44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	623-00-44H
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	04/09/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding dislocation (closed reduction) involving a trident liner was reported.The event was confirmed by medical review.Method and 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: ¿when seen on (b)(6) 2016 it was noted she had "dislocated on (b)(6) 2016.Emergency room closed reduction.X-ray slightly displaced fracture anterior wall".On (b)(6) 2016 the office notes states, "no further dislocations.¿ ¿in this obese woman, the primary total hip arthroplasty through an anterolateral approach used a 60 mm shell after reaming to 58 millimeters, which likely compromised the acetabular bone stock.It should be noted that no symptoms referable to the hip are documented prior to the patient's "fell on right side" and developing "deep pain with weightbearing" subsequent to which x-ray revealed "periacetabular fracture of the pelvis." at revision five years later in which acetabular deficiency was noted, the acetabulum was reamed to 65 millimeters for a 66 mm revision component, further compromising acetabular bone stock.Four months later, when the acetabular bone was severely deficient, plate fixation, cage reconstruction and bone grafting was required on a second revision.There is no evidence that factors of component design, manufacturing or materials were responsible for this clinical situation.¿ 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 event for dislocation (closed reduction) was confirmed.Based on the medical documentation and x-rays provided the patient experienced a dislocation and closed reduction 1 month past revision.The root cause of the dislocation could not be determined.It was noted that there was a fracture on the anterior wall of the acetabulum.As noted there were no further dislocations.Device remains implanted.
Event or Problem Description
Per medical review: when seen on (b)(6) 2016 it was noted she had "dislocated on (b)(6) 2016.Emergency room closed reduction.X-ray slightly displaced fracture anterior wall".On (b)(6) 2016 the office note states, "no further dislocations.Pain down posterior leg.

• Brand Name: TRIDENT 0 DEG INSERT 44MM
• 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: 7655708
• Report Number: 0002249697-2018-02013
• Device Sequence Number: 13492546
• Product Code: LPH
• UDI-Device Identifier: 07613327025408
• UDI-Public: 07613327025408
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K061434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/02/2018

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: 10/30/2017
• Device Catalogue Number: 623-00-44H
• Device Lot Number: MLNDAR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 07/02/2018
• 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: Other; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 104