MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM CLUSTER48D; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	702-04-48D
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Unequal Limb Length (4534); Insufficient Information (4580)
Date of Event	01/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "the surgeon states that the acetabular implant was not medialized enough causing the patient to be 1cm longer on the operative side.Surgeon pulled the insignia stem to make it easier to access and revise cup position.Nothing was wrong with stem or stem positioning." spoke to rep, who confirmed that there are no allegations against the revised liner, head, or dome hole cover.
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.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.Device not returned to the manufacturer.
Event or Problem Description
As reported: "the surgeon states that the acetabular implant was not medialized enough causing the patient to be 1cm longer on the operative side.Surgeon pulled the insignia stem to make it easier to access and revise cup position.Nothing was wrong with stem or stem positioning." spoke to rep, who confirmed that there are no allegations against the revised liner, head, or dome hole cover.
Additional Manufacturer Narrative
Reported event: an event regarding malposition involving a trident ii shell was reported.The event was confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical information by a clinical consultant indicated: "this inquiry reports the early revision of a left total hip replacement 5 days after implantation for a 1 cm leg length increase after surgery.The surgeon elected to revise the hip and reports that the stem had to be removed to access the cup.The surgeon felt the discrepancy was due to the cup being not medialized enough and he wanted to reposition the cup.I can confirm that this event took place since i was able to review the pre and post revision xrays.Regarding the possible root cause of this event, i cannot determine it with certainty.I question this strategy since moving the cup in a medial direction will not shorten the limb.In addition, the post revision xray measures 2mm longer that the pre revision xray.Malposition of the cup in the superior direction results in a shortened hip and malposition in the inferior direction can result in lengthening.Leg length discrepancy after total hip replacement is a common complication.It is surgical technique in origin and not related to implant or patient factors." -product history review: review of the device history records indicate 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 lot referenced.Conclusions: it was reported that the patient was revised due to malposition of the shell that was causing a leg length discrepancy.A review of the provided medical information by a clinical consultant indicated: "this inquiry reports the early revision of a left total hip replacement 5 days after implantation for a 1 cm leg length increase after surgery.The surgeon elected to revise the hip and reports that the stem had to be removed to access the cup.The surgeon felt the discrepancy was due to the cup being not medialized enough and he wanted to reposition the cup.I can confirm that this event took place since i was able to review the pre and post revision xrays.Regarding the possible root cause of this event, i cannot determine it with certainty.I question this strategy since moving the cup in a medial direction will not shorten the limb.In addition, the post revision xray measures 2mm longer that the pre revision xray.Malposition of the cup in the superior direction results in a shortened hip and malposition in the inferior direction can result in lengthening.Leg length discrepancy after total hip replacement is a common complication.It is surgical technique in origin and not related to implant or patient factors." the cause of the event is likely surgical technique-related but this cannot be concluded with certainty from the information provided.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIDENTII TRITANIUM CLUSTER48D
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13502441
• Report Number: 0002249697-2022-00206
• Device Sequence Number: 5387935
• Product Code: LPH
• UDI-Device Identifier: 07613327343861
• UDI-Public: 07613327343861
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K161569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2022

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 Model Number: 702-04-48D
• Device Catalogue Number: 702-04-48D
• Device Lot Number: 86610701A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 04/15/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 60 KG