MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM MULTI 50D; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 709-04-50D

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Ambulation Difficulties (2544)

Event Date 06/07/2023

Event Type  Injury  

Manufacturer Narrative

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.Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: tridentii tritanium cluster48d;702-04-48d;10419251a.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

As reported: "dr.Revised a left hip he originally did via mako to a competitor revision cup/cage construct and changed the head.This was due to pelvic fracture during the original surgery and subsequent failure post-op.During the original surgery, dr.Noticed during cup impaction the anterior wall of the acetabulum had a fracture.This is when he changed from a 48 primary cup to a sz 50 multi-hole intra-op.Post-op he said the patient couldn't walk and therefore decided to revise the cup side.He noted the bone quality was very poor.The revision surgery he kept the original exeter stem in place." spoke to rep.Rep confirmed that on (b)(6) 2023 the size 48 shell was impacted, acetabulum fracture was noted, 48 was removed and a 50 implanted.5 days later on (b)(6) 2023, the 50 shell was removed and competitor acetabular components implanted.Tha 4.1.

Event Description

As reported: "dr.Revised a left hip he originally did via mako to a competitor revision cup/cage construct and changed the head.This was due to pelvic fracture during the original surgery and subsequent failure post-op.During the original surgery, dr.Noticed during cup impaction the anterior wall of the acetabulum had a fracture.This is when he changed from a 48 primary cup to a sz 50 multi-hole intra-op.Post-op he said the patient couldn't walk and therefore decided to revise the cup side.He noted the bone quality was very poor.The revision surgery he kept the original exeter stem in place." spoke to rep.Rep confirmed that on (b)(6) /2023 the size 48 shell was impacted, acetabulum fracture was noted, 48 was removed and a 50 implanted.5 days later on (b)(6) 2023, the 50 shell was removed and competitor acetabular components implanted.Tha 4.1.

Manufacturer Narrative

Reported event: an event regarding intraoperative fracture and malposition involving a trident ii shell was reported.The event was confirmed through medical review.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 clinician review of the provided medical records states the following: "an acetabular revision was reportedly performed on a mako hip case presumably for acetabular instability.At the index procedure and acetabular fracture occurred.The original cup was replaced with a larger cup at that time.Unfortunately, the patient was unable to walk and required revision.Event confirmation: a left total hip arthroplasty with a mako plan can be confirmed.Cup malposition with acetabular fracture can be confirmed.The revision surgery cannot be confirmed.Root cause: the root cause of the unconfirmed revision would be instability of the acetabular component due to the underlying intraoperative acetabular fracture.The root cause of the intraoperative acetabular fracture would be most likely surgical technique related.-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.Conclusion: it was reported that during cup impaction, the anterior wall of the acetabulum had a fracture, a size 48 shell was removed and a size 50 shell was implanted.Five days later the size 50 shell was removed and competitor acetabular components implanted.A clinician review of the provided medical records states the following: "an acetabular revision was reportedly performed on a mako hip case presumably for acetabular instability.At the index procedure and acetabular fracture occurred.The original cup was replaced with a larger cup at that time.Unfortunately, the patient was unable to walk and required revision.Event confirmation: a left total hip arthroplasty with a mako plan can be confirmed.Cup malposition with acetabular fracture can be confirmed.The revision surgery cannot be confirmed." based on the robotic arm investigation.These are the findings that determine user error as the root cause.Based on the analysis of the relevant log files and session file: the rio system was performing within its specifications there is no indication of system malfunction.There is no indication of a bumped bone or base array.All interoperative surgical outcomes (pre-surgery checks, robot registration, bone registration, probe check) were successful.From the interoperative results there is no indication that system was performing outside of its specifications.The root cause of this issue could be aggressive reaming as this is very much evident from motor torque warnings in j4 and j5, also the downsizing the reamer was done rather than reaming with a larger reamer which can cause the reamer to catch on the deeper whole stressing the stereotactic and robotic arm.Impaction data indicates aggressive impaction.Rule of thumb is if the impaction is deep, this have fractured bone.Surgeon impacted to 4 mm deep on 1st impaction and 6 mm deep on 2nd impaction this cannot happen without a faulty reamer selection with a different size physical reamer or a fractured pelvis.There are ways by which this could have been avoided : 1.Do not impact past the 2mm proud without evaluating implant depth 2.Do not ream with a smaller reamer size after upsizing to the reamer size corresponding to the implant cup size selection 3.Be sure to match the reamer size with the physical reamer used to create an accurate burr list which generates the target point for depth of impaction.

• Brand Name: TRIDENTII TRITANIUM MULTI 50D
• Type of Device: 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17245872
• MDR Text Key: 318280906
• Report Number: 0002249697-2023-00744
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327343953
• UDI-Public: 07613327343953
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171768
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/24/2023

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 Model Number: 709-04-50D
• Device Catalogue Number: 709-04-50D
• Device Lot Number: 99345001A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2023
• Initial Date FDA Received: 07/03/2023
• Supplement Dates Manufacturer Received: 08/01/2023
• Supplement Dates FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female