MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 4 ACCOLADE II 132 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6720-0435
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Unequal Limb Length (4534)
Date of Event	10/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding limb length discrepancy involving an accolade stem was reported.The event was confirmed via clinician review of the provided medical records.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 records by a clinical consultant indicated: "i can confirm that the patient had a primary right and left total hip arthroplasty because i was able to review x-rays with the implants in place.I can also confirm that the patient underwent revision of the left total hip arthroplasty in order to shorten the limb because of a significant leg length discrepancy postoperatively because i was able to review the operation report and the post revision x-rays.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of leg length discrepancy following total hip arthroplasty are multi factorial, including surgical technique, preoperative planning, and whether or not the preoperative plan was executed correctly.Since robotic assistance was utilized, the robotic protocol should be analyzed to make sure that there were no errors in execution of the preoperative plan.I would not assign any causality to the patient or the implants.N.B.Any and all explanted parts or prostheses should be submitted to stryker engineers for complete metallurgical and/or microscopic evaluation and analysis." -product history review: review of the product history records indicate the reported device was manufactured with no reported relevant 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 leg length discrepancy.A review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient had a primary right and left total hip arthroplasty because i was able to review x-rays with the implants in place.I can also confirm that the patient underwent revision of the left total hip arthroplasty in order to shorten the limb because of a significant leg length discrepancy postoperatively because i was able to review the operation report and the post revision x-rays.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of leg length discrepancy following total hip arthroplasty are multi factorial, including surgical technique, preoperative planning, and whether or not the preoperative plan was executed correctly.Since robotic assistance was utilized, the robotic protocol should be analyzed to make sure that there were no errors in execution of the preoperative plan.I would not assign any causality to the patient or the implants.N.B.Any and all explanted parts or prostheses should be submitted to stryker engineers for complete metallurgical and/or microscopic evaluation and analysis." no further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
This pi is for the revision 2 days post implantation.We had a mako rtha 4.1case in which we followed the robotic plan to match the other side.After the surgery, doctor reported one leg being 1.5 cm longer than the other.Patient was extremely unhappy and we had to proceed with a revision.Patient had lots of soft tissue issues and pelvic rotation that i think was the contributing factor to this discrepancy.However, the compliance department at the hospital wants an official investigation done into this case to make sure this was not a robotic error (associated pi).Doctor has changed his workflow to assess leg lengths prior to surgery and adjust our robotic plan accordingly moving forward.I need this complaint expedited as the compliance department of the hospital is waiting for the results of this.

• Brand Name: SIZE 4 ACCOLADE II 132 DEG
• 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23463157
• Report Number: 0002249697-2025-01296
• Device Sequence Number: 8945743
• Product Code: LPH
• UDI-Device Identifier: 04546540664471
• UDI-Public: 04546540664471
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/04/2025

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 Catalogue Number: 6720-0435
• Device Lot Number: 27097453A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2025
• 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: 60 YR
• Patient Sex: Female