MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6020-0537
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Reaction (2414)
Date of Event	05/24/2019
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
It was reported that patient's right hip was revised due to disassociation of the head from the stem.Intra-operatively, an extreme amount of black tissue and discoloration of the liner were noted.Patient was revised to a competitor stem and head with a stryker liner.The shell was not revised.
Event or Problem Description
It was reported that patient's right hip was revised due to disassociation of the head from the stem.Intra-operatively, an extreme amount of black tissue and discoloration of the liner were noted.Patient was revised to a competitor stem and head with a stryker liner.The shell was not revised.
Additional Manufacturer Narrative
An event regarding disassociation and wear between an accolade stem and a metal head was reported.Disassociation and wear was confirmed through clinician review of the medical records provided and the mar.Method & results: -product evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated (b)(6) 2019 this inspection indicated hip stem damage was observed on the stem neck and trunnion consistent with loss of taper lock.Biological material was observed on each surface of the stem.Dimensional inspection: not performed as the reported device was implanted and subsequently explanted.The device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Functional inspection: not performed as the reported device was implanted and subsequently explanted.The device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Material analysis a material analysis has been performed.The report concluded: damage was observed on the stem neck and trunnion consistent with the loss of taper lock.The damage present on the articulating surface of the insert is consistent with burnishing, scratching and third body indentations; which are common damage modes of uhmwpe.The yellow discoloration on the liner is consistent with absorption of synovial fluid.Xrf showed the stem and head were consistent with an astm f1813 alloy and an astm f1537 alloy, respectively.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-clinican review: a review of the provided medical records by a clinical consultant stated the following comment: deemed insufficient for medical review [.]: provided x-ray confirms disassociation.Need operative reports, office/clinical reports, examination of the explanted components, etc.-product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: a material analysis has been performed.The report concluded: damage was observed on the stem neck and trunnion consistent with the loss of taper lock.The damage present on the articulating surface of the insert is consistent with burnishing, scratching and third body indentations; which are common damage modes of uhmwpe.The yellow discoloration on the liner is consistent with absorption of synovial fluid.Xrf showed the stem and head were consistent with an astm f1813 alloy and an astm f1537 alloy, respectively.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: ACCOLADE TMZF HIP STEM #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: 8715883
• Report Number: 0002249697-2019-02304
• Device Sequence Number: 2523170
• Product Code: LPH
• UDI-Device Identifier: 04546540510570
• UDI-Public: 04546540510570
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 09/25/2019

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: 04/30/2016
• Device Catalogue Number: 6020-0537
• Device Lot Number: 36600704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 09/25/2019
• 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: 84 YR