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

Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923); Positioning Problem (3009)

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

Event Date 09/18/2019

Event Type  Injury  

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 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.

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 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
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9196791
• MDR Text Key: 162974500
• Report Number: 0002249697-2019-03510
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327037265
• UDI-Public: 07613327037265
• Combination Product (y/n): N
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/16/2019
• Supplement Dates Manufacturer Received: 11/27/2019
• Supplement Dates FDA Received: 12/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 53