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	Degraded (1153)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/06/2018
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 similar events for the lot referenced.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
Event or Problem Description
It was reported that patient's hip was revised due to suspected trunnionosis.Rep was not present for procedure.No patient complaints, pre-operative diagnoses, reason for suspicion of trunnionosis, or intra-operative findings were reported to the rep.Primary and revision operative notes were provided.Patient's stem, femoral head, liner, and shell were revised.Reason for shell revision was not reported to the rep.
Additional Manufacturer Narrative
Reported event: an event regarding wear and infection between an accolade stem and a metal head was reported.The wear was confirmed following the completion of a material analysis report.Method & results: -product evaluation and results: visual inspection visual inspection was performed as part of the material analysis report (mar), dated 03 jan 2019.This inspection indicated.The returned devices were examined with the aid of a stereo microscope at magnifications up to 50x.Damages were observed on the neck of the stem, consistent with wear mechanisms due to the cyclic contact between the head taper and stem trunnion after the loss of their taper lock.Damage consistent with the explantation process in addition to biological fixation were also observed on 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 trunnion and head taper.This damage was consistent with wear mechanisms due to the cyclic contact between the head taper and stem trunnion after the loss of their taper lock.-clinican review: a review of the provided medical records by a clinical consultant stated the following comment: regarding the referenced pi, this case represents a male patient whose date of birth is (b)(6)1943, and who is described as 68-inches tall, weighing 247 pounds.On (b)(6)2007 he underwent a "left total hip replacement with computer assisted navigation" for a diagnosis of osteoarthritis of the left hip.An operative report describes general anesthesia and a posterior approach.The operative report notes, ".Three pins in the anterior iliac crest.Pins in distal femur.Reamed to 59" for, as implant labels confirm, a 60 trident hemispherical cup with two screws, a 40/0° x3 insert, a #5 accolade tmzf stem, and a 40/minus-4 v-40 lfit head.Uncomplicated surgery was described and the patient was discharged on (b)(6) 2007.[.] on (b)(6)2018 a revision of the left total hip arthroplasty with debridement of metalosis from left hip and abductors and incision and drainage of the left hip was performed for a pre- and post- operative diagnosis of "left total hip infection with metalosis".The operative report describes general anesthesia and use of the previous incision.The report further notes, ".Bulk of abductor completely intact.Large amount (30 to 40 ccs) of yellowish fluid in addition to large amount of grey metal debris.Apparent was loose femoral head.No attachment to trunnion, large amount of metal debris around trunnion.Removed femoral component with osteotomes and slap hammer.Acetabular cup quite lateral.With overhang over the bony socket.Removed liner, two screws and acetabulum with explant device.Frozen section: more than 5 neutrophils per high power field is consistent with diagnosis of mssa.Elected single stage.Reamed to 61 for 62 smith & nephew cup with four screws, cemented smith & nephew #13 femoral component with high load antibiotic cement, 36/plus 4 head, 36/20° liner." uncomplicated surgery was described and the patient was discharged on (b)(6)2018.A surgical pathology report dated (b)(6)2018 shows a final diagnosis of"a.Deep left hip biopsy.Several foci, up to 9 neutrophils per high power field; b.Acetabular reamings: reactive synovial tissue with black pigment deposition with chronic histocytic and lymphocytic inflammation.Focal acute inflammation.Several with more than 5 neutrophils per high power field, fragments of bone with remodeling, cartilage with reactive changes." an office visit on (b)(6)2018 notes, "x-ray of the left hip without hardware complication.Wound clean, dry and intact".On (b)(6)2018 it was noted, "doing well.Remains on po antibiotics".[.] nineteen photographs of the explanted stem, head, and acetabular shell with liner with evidence of either impingement or explantation trauma on the femoral stem/neck distal to the trunnion are reviewed.[.] there are no x-rays of the primary left total hip arthroplasty and no documented complaints or x-ray abnormalities related to the primary left total hip arthroplasty until the summer of 2018 after discontinuing antibiotics for treatment of an infected right total knee arthroplasty.There was only one mild elevation of plasma chromium of 4.4 (< 3.6 normal) on (b)(6)2018 and a normal cobalt of 1.4 (< 1.8 normal), which is not alarming in a patient eleven years status-post total hip arthroplasty and two years status­ post total knee arthroplasty which also includes cobalt-chromium components.There is no histopathologic evidence of altr due to metalosis noted in the revision pathology report for the surgery for the infected total hip arthroplasty.Based upon the information available for review, no determination can be made for the findings consistent with loss of stem/head taper lock noted at the revision for infection performed eleven years post-operative on the hip that was essentially asymptomatic until a few months previous to revision and developing an infection, likely from the previously infected right total knee arthroplasty.-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 or reported sterile lot.Conclusion: a material analysis concluded: damage was observed on the stem trunnion and head taper.This damage was consistent with wear mechanisms due to the cyclic contact between the head taper and stem trunnion after the loss of their taper lock.The exact cause of the reported event could not be determined based on the information provided.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that patient's hip was revised due to suspected trunnionosis.Rep was not present for procedure.No patient complaints, pre-operative diagnoses, reason for suspicion of trunnionosis, or intra-operative findings were reported to the rep.Primary and revision operative notes were provided.Patient's stem, femoral head, liner, and shell were revised.Reason for shell revision was not reported to the rep.

• 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: 7958740
• Report Number: 0002249697-2018-03294
• Device Sequence Number: 930414
• Product Code: LPH
• UDI-Device Identifier: 04546540510570
• UDI-Public: 04546540510570
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2019

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: 11/30/2012
• Device Catalogue Number: 6020-0537
• Device Lot Number: 20804101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Initial Date Received by Manufacturer: 09/13/2018
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 07/22/2019
• 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: 75 YR