MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 6 ACCOLADE II 132 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6720-0635
Medical Device Problem Codes	Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Date of Event	03/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the patient, he had a right tha done in dec 21, 2020.Patient started to experience pain approx.Three months after his surgery.The patient is also experiencing popping, swelling and leg discrepancy.The patient has an upcoming revision surgery scheduled for (b)(6).Patient wants assistance in getting better.Update as per med review, x-rays taken on that date showed "what appear to be a radiolucency around the porous coating laterally and medially and the stem appears to have sunk slightly.There is the beginning of a pedestal at the distal tip of the stem immediately and laterally." the socket appeared well fixed.It was felt that the patient's pain was related to loosening of the femoral stem and a workup was performed including to rule out infection.
Additional Manufacturer Narrative
Reported event: an event regarding loosening and limb length discrepancy involving an accolade stem.The event was not 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 records by a clinical consultant indicated: this inquiry reports the failure of a total hip replacement about 1 year after implantation due to femoral loosening.I cannot confirm that this event took place since i was not able to see xrays showing the signs of loosening, although the surgeon documented findings consistent with loosening in his office notes.No revision operation report is provided.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of early femoral loosening are multifactorial including surgical technique (and approach) factors, patient activity level and bmi factors, as well as implant 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.Conclusion: a review of the provided medical records by a clinical consultant indicated: this inquiry reports the failure of a total hip replacement about 1 year after implantation due to femoral loosening.I cannot confirm that this event took place since i was not able to see xrays showing the signs of loosening, although the surgeon documented findings consistent with loosening in his office notes.No revision operation report is provided.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of early femoral loosening are multifactorial including surgical technique (and approach) factors, patient activity level and bmi factors, as well as implant factors.Further information such as post-operative x-rays and revision operative reports are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Additional Manufacturer Narrative
Reported event: an event regarding loosening and limb length discrepancy involving an accolade stem.The event was not 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 records by a clinical consultant indicated: this inquiry reports the failure of a total hip replacement about 1 year after implantation due to femoral loosening.I cannot confirm that this event took place since i was not able to see x-rays showing the signs of loosening, although the surgeon documented findings consistent with loosening in his office notes.No revision operation report is provided.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of early femoral loosening are multifactorial including surgical technique (and approach) factors, patient activity level and bmi factors, as well as implant 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.Conclusion: a review of the provided medical records by a clinical consultant indicated: this inquiry reports the failure of a total hip replacement about 1 year after implantation due to femoral loosening.I cannot confirm that this event took place since i was not able to see x-rays showing the signs of loosening, although the surgeon documented findings consistent with loosening in his office notes.No revision operation report is provided.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of early femoral loosening are multifactorial including surgical technique (and approach) factors, patient activity level and bmi factors, as well as implant factors.Further information such as post-operative x-rays and revision operative reports are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported by the patient, he had a right tha done in (b)(6), 2020.Patient started to experience pain approx.Three months after his surgery.The patient is also experiencing popping, swelling and leg discrepancy.The patient has an upcoming revision surgery scheduled for (b)(6).Patient wants assistance in getting better.Update as per med review, x-rays taken on that date showed "what appear to be a radiolucency around the porous coating laterally and medially and the stem appears to have sunk slightly.There is the beginning of a pedestal at the distal tip of the stem immediately and laterally." the socket appeared well fixed.It was felt that the patient's pain was related to loosening of the femoral stem and a workup was performed including to rule out infection.

• Brand Name: SIZE 6 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 14403176
• Report Number: 0002249697-2022-00703
• Device Sequence Number: 5452020
• Product Code: LPH
• UDI-Device Identifier: 04546540664495
• UDI-Public: 04546540664495
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K103479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2022

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 Expiration Date: 10/31/2024
• Device Model Number: 6720-0635
• Device Catalogue Number: 6720-0635
• Device Lot Number: 74348906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 05/14/2022
• Supplement Report FDA Received Date: 05/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2019
• 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: Other
• Patient Age: 52 YR
• Patient Sex: Male