MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM CLUSTER54E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	702-04-54E
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Loss of Osseointegration (2408); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	10/17/2017
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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
As reported: "patient with primary [left] tha on (b)(6) 2017.Underwent subsequent revision for mechanical complications.Lytic lesions behind acetabular component and stem subsidence were noted on radiographs before revision.All components revised".
Additional Manufacturer Narrative
Additional information: event description an event regarding lytic lesions behind acetabular component (patient factors) involving a trident shell was reported.A medical review confirm loosening of the shell.Method & results: -product evaluation and results: not performed as the device was not returned.-medical records received and evaluation: the medical review concluded the following: [.] conclusion of assessment a periprosthetic fracture occurred either during during primary arthroplasty due to mismatch between stem size and bone strength or early post implantation due to trauma or other overload condition by the patient.The pp-fracture caused stem subsidence with additionally secondary lack of bone ingrowth fixation of the cup shell with pain and dysfunction of the left hip arthroplasty requiring revision within 10-months of implantation.Availability of early post implantation x-rays might allow to differentiate between the two possible failure scenario¿s.Does the review identify any procedural related factors that contributed to the event? - mismatch between stem size and bone strength due to osteoporosis a likely contributing factor does the review identify any patient related factors that contributed to the event? - osteoporosis with reduced bone strength a likely contributing factor - a traumatic overload condition due to fall, stumbling or otherwise early post implantation may have represented the trigger for occurrence of the pp-fracture - the absence of early postoperative x-rays prevents to differentiate between the procedure-related or patient-related failure scenario although one of the two certainly applies.Does the review identify any device related factors that caused or contributed to the adverse event? - no device-related factors are associated with any of the implanted devices.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there were no other events for the lot provided.Conclusions: the medical review concluded the following: [.] a periprosthetic fracture occurred either during during primary arthroplasty due to mismatch between stem size and bone strength or early post implantation due to trauma or other overload condition by the patient.The pp-fracture caused stem subsidence with additionally secondary lack of bone ingrowth fixation of the cup shell with pain and dysfunction of the left hip arthroplasty requiring revision within 10-months of implantation.Availability of early post implantation x-rays might allow to differentiate between the two possible failure scenario¿s.[.] no further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
As reported: "patient with primary [left] tha on (b)(6)2017.Underwent subsequent revision for mechanical complications.Lytic lesions behind acetabular component and stem subsidence were noted on radiographs before revision.All components revised".Update (b)(6)2018: medical review completed.The review confirmed loosening of the shell and a periprosthetic femoral fracture.The review stated: [.] the pp-fracture caused stem subsidence with additionally secondary lack of bone ingrowth fixation of the cup shell with pain and dysfunction of the left hip arthroplasty requiring revision within 10-months of implantation.[.].

• Brand Name: TRIDENTII TRITANIUM CLUSTER54E
• 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: 7420818
• Report Number: 0002249697-2018-01078
• Device Sequence Number: 554860
• Product Code: LPH
• UDI-Device Identifier: 07613327344073
• UDI-Public: 07613327344073
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K161569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2018

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: 11/30/2021
• Device Catalogue Number: 702-04-54E
• Device Lot Number: 57844801
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 04/11/2018
• Supplement Report FDA Received Date: 06/25/2018
• 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: 75 YR
• Patient Weight: 81