MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG CONSTRAINED INSERT 22D; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number	690-00-22D
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348); Joint Dislocation (2374)
Date of Event	07/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.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.Device not returned.
Event or Problem Description
As reported: "pain and dislocation.Previous trochanteric fracture.All available information provided".Pre-revision x-ray shows the metal ring of the constrained liner around the femoral head, all of which is out of the shell.Patient was revised to an mdm 38d liner with a 22 +3 head.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving a trident liner was reported.The event was confirmed through clinician review of the medical records provided.Method & results: product evaluation and results: not performed as no product was returned for evaluation.Clinician review: a review of the provided medical records revealed: review of these records confirms dissociation of the constrained liner from the acetabular shell did occur.The root cause of the mechanical failure and dissociation of the constrained liner from the acetabular shell cannot be determined as insufficient information was available.The patient has a chronic trochanteric nonunion with inability to stabilize the proximal fragment.The abductor muscles that serve to stabilize the hip are attached to this proximal fragment and its lack of fixation leads to the inevitable instability of the hip necessitating the constrained liner.With lack of supporting soft tissue stabilization of the hip all the forces tending to dislocate the hip are concentrated at the constrained liner head articulation and the interface and capture mechanism of the shell and constrained liner which in this case went on to failure.The root cause of this mechanical failure and subsequent dissociation of the constrained liner from the acetabular shell cannot be determined as insufficient information was available.Product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the medical review revealed: a review of the provided medical records revealed: review of these records confirms dissociation of the constrained liner from the acetabular shell did occur.The root cause of the mechanical failure and dissociation of the constrained liner from the acetabular shell cannot be determined as insufficient information was available.The patient has a chronic trochanteric nonunion with inability to stabilize the proximal fragment.The abductor muscles that serve to stabilize the hip are attached to this proximal fragment and its lack of fixation leads to the inevitable instability of the hip necessitating the constrained liner.With lack of supporting soft tissue stabilization of the hip all the forces tending to dislocate the hip are concentrated at the constrained liner head articulation and the interface and capture mechanism of the shell and constrained liner which in this case went on to failure.The root cause of this mechanical failure and subsequent dissociation of the constrained liner from the acetabular shell cannot be determined as insufficient information was available.Further information such as dated pre and post operative x-rays, imaging from all previous surgeries, outpatient office/clinic notes and product return are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
As reported: "pain and dislocation.Previous trochanteric fracture.All available information provided".Pre-revision x-ray shows the metal ring of the constrained liner around the femoral head, all of which is out of the shell.Patient was revised to an mdm 38d liner with a 22 +3 head.

• Brand Name: TRIDENT 0 DEG CONSTRAINED INSERT 22D
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7728750
• Report Number: 0002249697-2018-02350
• Device Sequence Number: 16369899
• Product Code: KWZ
• UDI-Device Identifier: 07613327025538
• UDI-Public: 07613327025538
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K061654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2018

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: 06/30/2022
• Device Catalogue Number: 690-00-22D
• Device Lot Number: D73LJ9
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 07/27/2018
• Supplement Report FDA Received Date: 09/12/2018
• 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: 87 YR
• Patient Weight: 52