MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 3.5 ACCOLADE (127 DEG) SIZE 3.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6021-3535
Medical Device Problem Codes	Degraded (1153); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Metal Related Pathology (4530)
Date of Event	03/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his right hip on or about (b)(6) 2012 and was revised on (b)(6) 2022.It is further alleged that he suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in his blood.
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his right hip on or about (b)(6) 2012 and was revised on (b)(6) 2022.It is further alleged that he suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in his blood.Update based on medical review dated 09 july 2022.This inquiry reports the case of femoral head disassociation and erosion of the femoral trunnion.This occurred approximately 10 years after initial implantation.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation and abnormal ion level involving an accolade stem was reported.The event was confirmed through clinician review of the provided medical records.Method & results: -device 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 case of femoral head disassociation and erosion of the femoral trunnion.This occurred approximately 10 years after initial implantation.The implants themselves were well fixed.The patient did have symptoms for over two years prior to seeking attention which possibly could have contributed to this failure.Review of the x-rays revealed the acetabular component to be in neutral version.In my experience this can cause impingement in flexion which also could contribute to this failure.This failure is related to the articulation between the femoral head and femoral trunnion.No other implants are involved in this phenomena.I can confirm that this event occurred since i was able to review the pre-revision xray.The root cause of femoral head disassociation and femoral trunnion erosion is multifactorial including surgical technique, patient factors such as bmi and activity level, and implant factors.-device history review: review of the device history records indicate the 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 case of femoral head disassociation and erosion of the femoral trunnion.This occurred approximately 10 years after initial implantation.The implants themselves were well fixed.The patient did have symptoms for over two years prior to seeking attention which possibly could have contributed to this failure.Review of the x-rays revealed the acetabular component to be in neutral version.In my experience this can cause impingement in flexion which also could contribute to this failure.This failure is related to the articulation between the femoral head and femoral trunnion.No other implants are involved in this phenomena.I can confirm that this event occurred since i was able to review the pre-revision xray.The root cause of femoral head disassociation and femoral trunnion erosion is multifactorial including surgical technique, patient factors such as bmi and activity level, and implant factors.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.

• Brand Name: ACCOLADE (127 DEG) SIZE 3.5 ACCOLADE (127 DEG) SIZE 3.5
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 14493771
• Report Number: 0002249697-2022-00754
• Device Sequence Number: 14895215
• Product Code: LPH
• UDI-Device Identifier: 04546540510754
• UDI-Public: 04546540510754
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2022

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: 02/28/2017
• Device Model Number: 6021-3535
• Device Catalogue Number: 6021-3535
• Device Lot Number: 39134101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2012
• 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: Male