MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	542-11-50E
Medical Device Problem Codes	Malposition of Device (2616); Device Dislodged or Dislocated (2923); Positioning Problem (3009)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	09/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant 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
Patient stood up and dislocated his hip.The event occurred out of hospital.Dr believed that by repositioning the acetabular shell, it would solve the problem of dislocation in the future.The femoral head and acetabular components were removed and replaced this new implants.
Additional Manufacturer Narrative
An event regarding malposition involving a trident shell was reported.The event was confirmed via medical review.Method & results: device evaluation and results: the reported device was not returned however an x-ray was provided for review.The x-ray shows a recently explanted trident shell well affixed to the patient¿s acetabulum.From the photographs provided there is evidence of dislocation for the device from the metal head/stem construct.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated ¿no clinical or past medical history, no dated labeled serial x-rays, and no examination of explanted components are available.The single x-ray confirms the event description and suggests the instability was the result of acetabular malpositioning, rather than factors associated with implant design, manufacturing or materials.¿ device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: a review of the provided medical records and x-rays by a clinical consultant indicated ¿no clinical or past medical history, no dated labeled serial x-rays, and no examination of explanted components are available.The single x-ray confirms the event description and suggests the instability was the result of acetabular malpositioning, rather than factors associated with implant design, manufacturing or materials.¿ 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
Patient stood up and dislocated his hip.The event occurred out of hospital.Dr believed that by repositioning the acetabular shell, it would solve the problem of dislocation in the future.The femoral head and acetabular components were removed and replaced this new implants.

• Brand Name: TRIDENT PSL HA CLUSTER 50MM
• 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: 9196791
• Report Number: 0002249697-2019-03510
• Device Sequence Number: 19570724
• Product Code: LPH
• UDI-Device Identifier: 07613327037265
• UDI-Public: 07613327037265
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 12/26/2019

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 Expiration Date: 12/31/2021
• Device Catalogue Number: 542-11-50E
• Device Lot Number: 57485702
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 12/26/2019
• 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 Age: 86 YR
• Patient Weight: 53