MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #6; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6020-0637
Medical Device Problem Codes	Material Erosion (1214); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530)
Date of Event	10/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device evaluated by manufacturer? not returned.
Event or Problem Description
Dr.Reported: "disassembly of the prosthetic implant left hip on (b)(6) 2020.Prosthetic implant worn.On (b)(6) 2020 patient operated for revision.Periprosthetic metallosis with wear of the femoral neck of the stem.Stem and head explanted and replaced with a revision prosthetic".
Additional Manufacturer Narrative
Reported event: an event regarding disassociation and fretting involving an accolade stem was reported.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: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate 12 devices were manufactured and accepted into final stock on 29-nov-2006 with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the components were disassociated and periprosthetic metallosis with wear of the femoral neck of the stem was noticed during revision surgery.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report 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.H3 other text : device not returned.
Event or Problem Description
Dr.Reported: "disassembly of the prosthetic implant left hip on (b)(6) 2020.Prosthetic implant worn.On (b)(6) 2020, patient operated for revision.Periprosthetic metallosis with wear of the femoral neck of the stem.Stem and head explanted and replaced with a revision prosthetic".

• Brand Name: ACCOLADE TMZF HIP STEM #6
• 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: 10902783
• Report Number: 0002249697-2020-02533
• Device Sequence Number: 11378943
• Product Code: LPH
• UDI-Device Identifier: 04546540510587
• UDI-Public: 04546540510587
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2021

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: 11/30/2011
• Device Model Number: 6020-0637
• Device Catalogue Number: 6020-0637
• Device Lot Number: 20715801
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 01/18/2021
• 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