MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 10 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6721-1040
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding instability involving an accolade stem was reported.The event was not confirmed.Method & results: device evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device is still implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated: "this case concerns a 53-year-old male patient who underwent a primary cementless total hip arthroplasty in 2018.In 2024 the patient developed instability which was felt to be due to impingement and revision was carried out, replacing a 10° liner with a 0° eccentric liner.Confirmation of event: i can confirm that the patient had a primary total hip arthroplasty on the right since i was able to review an x-ray with the implant in place.I was able to review implant sheets from the primary procedure and also from the revision procedure but i have no other documentation such as a revision operation report or a post revision x-ray.Root cause analysis: the root cause of this event cannot be determined with certainty based upon the information provided.According to the summary, it was felt that we current instability was due to impingement posteriorly however no documentation is provided for this.Also, it would be unusual for improvement develop six years after surgery unless there was a change in position of the implant or polyethylene wear.If indeed the instability was due to impingement, then that would be an iatrogenic event caused by malposition of the implants, or failure to remove osteophytes, etc.Other causes of late instability could be trauma or stretching of the capsular structures, or a change in the position of the components or polyethylene wear." device history review: review of the device history records indicate 8 devices were manufactured and accepted into final stock on dec 5, 2016 with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Investigation: the exact cause of the event could not be determined because insufficient information was provided.A review of the provided medical records by a clinical consultant indicated: "this case concerns a 53-year-old male patient who underwent a primary cementless total hip arthroplasty in 2018.In 2024 the patient developed instability which was felt to be due to impingement and revision was carried out, replacing a 10° liner with a 0° eccentric liner.Confirmation of event: i can confirm that the patient had a primary total hip arthroplasty on the right since i was able to review an x-ray with the implant in place.I was able to review implant sheets from the primary procedure and also from the revision procedure but i have no other documentation such as a revision operation report or a post revision x-ray.Root cause analysis: the root cause of this event cannot be determined with certainty based upon the information provided.According to the summary, it was felt that we current instability was due to impingement posteriorly however no documentation is provided for this.Also, it would be unusual for improvement develop six years after surgery unless there was a change in position of the implant or polyethylene wear.If indeed the instability was due to impingement, then that would be an iatrogenic event caused by malposition of the implants, or failure to remove osteophytes, etc.Other causes of late instability could be trauma or stretching of the capsular structures, or a change in the position of the components or polyethylene wear." further information such as return of the device, pathology reports, pre- and post-operative x-rays as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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
Patient revised due to instability.This is the right side.Dr.Thought the patient was impinging posteriorly so we put in a neutral liner.We wasted a liner as it still felt unstable, and we implanted the 0° eccentric liner listed on the sheet.No other information available due to hospital policy.

• Brand Name: SIZE 10 ACCOLADE II 127 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: 19015533
• Report Number: 0002249697-2024-00526
• Device Sequence Number: 17113667
• Product Code: LPH
• UDI-Device Identifier: 04546540669551
• UDI-Public: 04546540669551
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/01/2024

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: 12/01/2021
• Device Catalogue Number: 6721-1040
• Device Lot Number: 57336502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2016
• 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: 53 YR
• Patient Sex: Male