MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 8 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6721-0837
Medical Device Problem Codes	Degraded (1153); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	03/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
Head disassociated from the stem.
Additional Manufacturer Narrative
An event regarding disassociation and fretting involving a accolade stem which was mated with a lfit v40 cocr head was reported.The event was confirmed through clinician review of the provided medical records.Method & results -product evaluation and results: the device was returned for evaluation.Damage is visible on the stem trunnion.Damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.This has been documented as part of a capa.No further material analyses were performed.-medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated: "patient underwent primary left total hip arthroplasty.Eight years later the implant failed due to corrosion, metallosis and disassociation of the femoral head off the trunnion.I can confirm that the event occurred since i was able to review the operative reports and i reviewed the x-rays.Regarding the possible root cause of this event, i cannot determine this for sure.Causes could be multi factorial including in adequate cleansing and drying of the trunnion and possibly the combination of a high offset femoral head coupled with a 127 degree neck shaft angle.This cannot be determined with certainty." -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.Conclusion: a review of the provided medical records by a clinical consultant indicated: "patient underwent primary left total hip arthroplasty.Eight years later the implant failed due to corrosion, metallosis and disassociation of the femoral head off the trunnion.I can confirm that the event occurred since i was able to review the operative reports and i reviewed the x-rays.Regarding the possible root cause of this event, i cannot determine this for sure.Causes could be multi factorial including in adequate cleansing and drying of the trunnion and possibly the combination of a high offset femoral head coupled with a 127 degree neck shaft angle.This cannot be determined with certainty." 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 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
Head disassociated from the stem.

• Brand Name: SIZE 8 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
• MDR Report Key: 11645426
• Report Number: 0002249697-2021-00660
• Device Sequence Number: 11512805
• Product Code: LPH
• UDI-Device Identifier: 04546540669537
• UDI-Public: 04546540669537
• 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: 2013
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

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: 6721-0837
• Device Catalogue Number: 6721-0837
• Device Lot Number: 39398202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR