MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 2.5 ACCOLADE (127 DEG) SIZE 2.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6021-2530
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	11/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding pain involving a metal head that was mated with an accolade stem was reported.Disassociation was confirmed by 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.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review additional information related to pi including the product inquiry summary, implant record from a revision tha surgery, revision surgery operative report, physical therapy discharge note and an ap x-ray of a failed tha.The event description from the product inquiry summary states: patient had total hip 13 years ago and recently started to experience pain in her hip.The x-ray shows dissociation of the femoral head with deformation of the trunnion.The cup has lost fixation and is now oriented vertically.There is significant peri-acetabular osteolysis.All these findings are further described in the operative report which also mentions significant metallosis throughout the hip.Historically the surgeon notes that the patient had a chronically painful tha which went on to acute failure necessitating revision surgery.It is confirmed that the patient had a revision tha surgery related to failure of the trunnion and head interface with trunnion deformation and head dissociation.In addition, there was loss of fixation of the acetabular component.The root cause of this issue cannot be established by the limited documentation provided.Should additional information become available i would be happy to further this assessment.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of the provided medical records by a clinical consultant stated the following comment: a review of the provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review additional information related to pi including the product inquiry summary, implant record from a revision tha surgery, revision surgery operative report, physical therapy discharge note and an ap x-ray of a failed tha.The event description from the product inquiry summary states: patient had total hip 13 years ago and recently started to experience pain in her hip.The x-ray shows dissociation of the femoral head with deformation of the trunnion.The cup has lost fixation and is now oriented vertically.There is significant peri-acetabular osteolysis.All these findings are further described in the operative report which also mentions significant metallosis throughout the hip.Historically the surgeon notes that the patient had a chronically painful tha which went on to acute failure necessitating revision surgery.It is confirmed that the patient had a revision tha surgery related to failure of the trunnion and head interface with trunnion deformation and head dissociation.In addition, there was loss of fixation of the acetabular component.The root cause of this issue cannot be established by the limited documentation provided.Should additional information become available i would be happy to further this assessment.The reported accolade stem was mated with a lfit v40 cocr head.The cocr head has been identified to be within scope of an nc and capa.No further investigation for this event is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Patient had total hip 13 years ago and recently started to experience pain in her hip.Update as per med review comment: "the x-ray shows dissociation of the femoral head with deformation of the trunnion.The cup has lost fixation and is now oriented vertically.".
Additional Manufacturer Narrative
Reported event: an event regarding pain involving a metal head that was mated with an accolade stem was reported.Disassociation was confirmed by 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.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review additional information including the product inquiry summary, implant record from a revision tha surgery, revision surgery operative report, physical therapy discharge note and an ap x-ray of a failed tha.The event description from the product inquiry summary states: patient had total hip 13 years ago and recently started to experience pain in her hip.The x-ray shows dissociation of the femoral head with deformation of the trunnion.The cup has lost fixation and is now oriented vertically.There is significant peri-acetabular osteolysis.All these findings are further described in the operative report which also mentions significant metallosis throughout the hip.Historically the surgeon notes that the patient had a chronically painful tha which went on to acute failure necessitating revision surgery.It is confirmed that the patient had a revision tha surgery related to failure of the trunnion and head interface with trunnion deformation and head dissociation.In addition, there was loss of fixation of the acetabular component.The root cause of this issue cannot be established by the limited documentation provided.Should additional information become available i would be happy to further this assessment.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of the provided medical records by a clinical consultant stated the following comment: a review of the provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review additional information including the product inquiry summary, implant record from a revision tha surgery, revision surgery operative report, physical therapy discharge note and an ap x-ray of a failed tha.The event description from the product inquiry summary states: patient had total hip 13 years ago and recently started to experience pain in her hip.The x-ray shows dissociation of the femoral head with deformation of the trunnion.The cup has lost fixation and is now oriented vertically.There is significant peri-acetabular osteolysis.All these findings are further described in the operative report which also mentions significant metallosis throughout the hip.Historically the surgeon notes that the patient had a chronically painful tha which went on to acute failure necessitating revision surgery.It is confirmed that the patient had a revision tha surgery related to failure of the trunnion and head interface with trunnion deformation and head dissociation.In addition, there was loss of fixation of the acetabular component.The root cause of this issue cannot be established by the limited documentation provided.Should additional information become available i would be happy to further this assessment.The reported accolade stem was mated with a lfit v40 cocr head.The cocr head has been identified to be within scope of nc and capa.No further investigation for this event is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Patient had total hip 13 years ago and recently started to experience pain in her hip.Update as per med review comment: "the x-ray shows dissociation of the femoral head with deformation of the trunnion.The cup has lost fixation and is now oriented vertically.".

• Brand Name: ACCOLADE (127 DEG) SIZE 2.5 ACCOLADE (127 DEG) SIZE 2.5
• 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: 15037564
• Report Number: 0002249697-2022-01019
• Device Sequence Number: 5060726
• Product Code: LPH
• UDI-Device Identifier: 04546540510747
• UDI-Public: 04546540510747
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2022

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: 09/30/2012
• Device Model Number: 6021-2530
• Device Catalogue Number: 6021-2530
• Device Lot Number: 23956106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2007
• 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: Required Intervention; Hospitalization
• Patient Age: 87 YR
• Patient Sex: Female