MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE 132 SIZE 4.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6020-4535
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Inflammation (1932); Injury (2348); Reaction (2414)
Date of Event	04/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.Device evaluation is anticipated but not yet begun.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Patient had revision hip surgery because broken primary stem.Update 06-may-2019: rep provided an operative report for the (b)(6) 2019 revision which cites: "failed left total hip arthroplasty with complete resorption of the trunnion and significant metallosis diffusely about the hip coupled with significantly weak bone secondary to the metallosis.Polyethylene was removed which had an abnormal color to it secondary to the metallosis.Significantly worn posteriorly; however, there was no complete loss of polyethylene." rep also provided pre- and post-revision x-rays and reported that no further information will be released by the hospital or surgeon.Update: "black tissue was noted in the patient intra-operatively, pseudo-tumor was reported, no elevated ion levels and there was wear and discoloration of the liner reported.".
Additional Manufacturer Narrative
An event regarding wear/fretting/metallosis/altr (reported pseudotumor) involving an accolade stem mated with an unknown metal head was reported.The wear and metallosis event was confirmed based on the returned device and primary and revision operative reports and x-rays provided.Reported pseudotumor was not confirmed.Methods and results: device evaluation and results: material analysis of the returned device has concluded that the wear observed on the hip stem trunnion and neck is consistent with loss of the taper lock between the stem trunnion and the femoral head.Eds showed the stem was consistent with an astm f1813 alloy.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: a review of the provided primary and revision operative reports and x-rays by a clinical consultant indicated: no clinical or past medical history, or documentation between the(b)(6) 2009 and (b)(6) 2019 operative reports is available.There are no patient demographics and no surgical pathology report is available.The delay in the revision surgery from the apparent disassociation of the head/trunnion junction likely resulted in the ¿significant metalosis¿ noted at revision surgery as the trunnion continued to articulate with the metal head and/or the acetabular rim.No cause can be determined for the apparent loss of the trunnion /head interface locking which occurred ten years after implantation based upon the information available for review.The subsequent metalosis and intraoperative description of pathology was contributed to by the delay in surgical intervention.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: material analysis of the returned device has concluded that the wear observed on the hip stem trunnion and neck is consistent with loss of the taper lock between the stem trunnion and the femoral head.Eds showed the stem was consistent with an astm f1813 alloy.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.A review of the provided medical records and x-rays by a clinical consultant indicated: no clinical or past medical history, or documentation between the (b)(6) 2009 and (b)(6) 2019 operative reports is available.There are no patient demographics and no surgical pathology report is available.The delay in the revision surgery from the apparent disassociation of the head/trunnion junction likely resulted in the ¿significant metalosis¿ noted at revision surgery as the trunnion continued to articulate with the metal head and/or the acetabular rim.No cause can be determined for the apparent loss of the trunnion /head interface locking which occurred ten years after implantation based upon the information available for review.The subsequent metalosis and intraoperative description of pathology was contributed to by the delay in surgical intervention.While the disassociation, fretting and metallosis events were confirmed based on the returned product and provided primary and revision operative reports and x-rays, the exact cause of the event could not be determined because insufficient information was provided.Additional information including lot and catalog details of all mated devices, patient medical history, patient demographics and surgical pathology reports are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.
Event or Problem Description
Patient had revision hip surgery because broken primary stem.Update (b)(6) n019: rep provided an operative report for the (b)(6) 2019 revision which cites: "failed left total hip arthroplasty with complete resorption of the trunnion and significant metallosis diffusely about the hip coupled with significantly weak bone secondary to the metallosis polyethylene was removed which had an abnormal color to it secondary to the metallosis significantly worn posteriorly; however, there was no complete loss of polyethylene." rep also provided pre- and post-revision x-rays and reported that no further information will be released by the hospital or surgeon.Update: "black tissue was noted in the patient intra-operatively, pseudo-tumor was reported, no elevated ion levels and there was wear and discoloration of the liner reported".

• Brand Name: ACCOLADE 132 SIZE 4.5
• 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: 8649406
• Report Number: 0002249697-2019-02113
• Device Sequence Number: 14208238
• Product Code: LPH
• UDI-Device Identifier: 04546540510631
• UDI-Public: 04546540510631
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/09/2019

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: 11/30/2013
• Device Catalogue Number: 6020-4535
• Device Lot Number: 28248802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Initial Date Received by Manufacturer: 05/01/2019
• Supplement Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 09/09/2019
• 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: 70 YR