MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 32MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	623-10-32G
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Booked revision case due to dislocation post previous fracture.Head and liner revised from +0 head to +8 head and mdm.Mdm trialed on table and case completed.This pi is for the dislocation.
Additional Manufacturer Narrative
An event regarding recurrent dislocations due to incorrect selection involving trident liner was reported.The event was confirmed through review of the provided medical records and x-rays by a clinical consultant.Method & results: -device evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted trident liner.The poly liner has no obvious changes other than explantation damage.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.-medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: conclusion of assessment a marginally stable hip arthroplasty was present in 2014 with cup malposition in low inclination, mainly due to inappropriate use of a 10° offset liner in combination with a slightly short leg in the hip joint due to inadequate reconstruction of femoral head neck length.The marginal stability of the arthroplasty was further compromised after the `irst hip dislocation associated with a fall of the patient in 2018.This caused rupture of the hip capsule with loss of soft tissue stability in the joint and no prospect of adequate capsular healing due to further recurrent dislocation in short intervals.Recurrent dislocation required revision surgery with exchange of the bearing for an mdm construct with longer femoral head in jan 2019.-device history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusion: the investigation concluded that inappropriate use of a 10° offset liner contributed to the recurrent dislocations which led to this revision surgery.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
Booked revision case due to dislocation post previous fracture.Head and liner revised from +0 head to +8 head and mdm.Mdm trialed on table and case completed.This pi is for the dislocation.

• Brand Name: TRIDENT 10° X3 INSERT 32MM 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: 8311368
• Report Number: 0002249697-2019-00589
• Device Sequence Number: 2253558
• Product Code: LPH
• UDI-Device Identifier: 07613327039870
• UDI-Public: 07613327039870
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2019

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 Catalogue Number: 623-10-32G
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 05/02/2019
• 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 Weight: 85