MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6020-0230
Medical Device Problem Codes	Degraded (1153); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	10/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
As reported: "[left hip] revision surgery.Revised head ball, liner, dome hole plug, screw and stem.Acetabular cup was left and inspected - deemed intact.New liner and dome hole plug implanted.Head was disassociated off trunnion.Stem was unusually worn down.Stem revised and explanted as well as head.Unusual wear on stem trunnion".Rep provided pre- and post-revision x-rays, an excerpt of the operative report, and pictures of the explants.The liner pictured shows a noticeably damaged rim in one spot.Spoke to rep.Liner was in that condition in vivo.The devices are allegedly available for return, but no further information will be available.
Additional Manufacturer Narrative
An event regarding disassociation and wear involving an accolade stem was reported.The event was confirmed by visual analysis of the devices.Method & results: device evaluation and results: damage consistent with the loss of taper lock was observed on the stem neck and trunnion.No identifiable materials or manufacturing discrepancies were observed on the surfaces examined for the accolade stem.Clinician review: a review of the provided x-rays by a clinical consultant indicated: based upon the information available for review, no determination can be made regarding the cause of this clinical event occurring ten years post- implantation.Device history review: all 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 reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports and progress notes are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
As reported: "[left hip] revision surgery.Revised head ball, liner, dome hole plug, screw and stem.Acetabular cup was left and inspected - deemed intact.New liner and dome hole plug implanted.Head was disassociated off trunnion.Stem was unusually worn down.Stem revised and explanted as well as head.Unusual wear on stem trunnion".Rep provided pre- and post-revision x-rays, an excerpt of the operative report, and pictures of the explants.The liner pictured shows a noticeably damaged rim in one spot.Spoke to rep.Liner was in that condition in vivo.The devices are allegedly available for return, but no further information will be available.

• Brand Name: ACCOLADE TMZF HIP STEM #2
• 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: 9278164
• Report Number: 0002249697-2019-03678
• Device Sequence Number: 18918293
• Product Code: LPH
• UDI-Device Identifier: 04546540510549
• UDI-Public: 04546540510549
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2020

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: 08/31/2014
• Device Model Number: 6020-0230
• Device Catalogue Number: 6020-0230
• Device Lot Number: 30728201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 01/23/2020
• 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: 52 YR