MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	542-11-54F
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	08/29/2019
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 relevant reported discrepancies.There have been no other similar 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 dislocated their constrained liner from the cup again on (b)(6) 2019.On (b)(6) 2019, liner was revised to a constrained liner, trident constrained acetabular insert, size f, ref code: 690-00-28f, lot: lw556t.Patient has tertiary syphilis.This has manifested in the following ways according to the treating medical team, loss of muscular control and inhibition for neurological function.Is unable to understand or follow directions and daily puts their hips in extreme ranges of motion, as a consequence of their condition.This patient's original surgery was on (b)(6) 2019 and it was first revised on (b)(6) 2019 for dislocation.Patient revised again (b)(6) 2019 after a disassociation of a constrained liner on (b)(6) 2019 (pi 2154970).
Event or Problem Description
Patient dislocated their constrained liner from the cup again on (b)(6) 2019.On liner was revised to a constrained liner, trident constrained acetabular insert, size f, ref code: 690-00-28f, lot: lw556t patient has tertiary syphilis.This has manifested in the following ways according to the treating medical team, loss of muscular control and inhibition for neurological function.Is unable to understand or follow directions and daily puts their hips in extreme ranges of motion, as a consequence of their condition.This patient's original surgery was on(b)(6) 2019 and it was first revised on 12.6.19 for dislocation.Patient revised again (b)(6) 2019 after a disassociation of a constrained liner on (b)(6) 2019.
Additional Manufacturer Narrative
Correction: there has been one other similar events for the reported lot.An event regarding disassociation involving a trident shell was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as no product was returned for evaluation, the reported device remains implanted.-clinician review: no medical records were received for review with a clinical consultant.-device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there has been one other similar events for the reported lot.Pr 2113418 relates to the same patient.Conclusions: the event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as operative reports, progress notes, x-rays and return of the device 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.

• Brand Name: TRIDENT PSL HA CLUSTER 54MM
• 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: 9123635
• Report Number: 0002249697-2019-03332
• Device Sequence Number: 19416375
• Product Code: LPH
• UDI-Device Identifier: 07613327037203
• UDI-Public: 07613327037203
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2019

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: 12/31/2023
• Device Catalogue Number: 542-11-54F
• Device Lot Number: AP68YN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/29/2019
• Supplement Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 11/13/2019
• 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