MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 3.5 ACCOLADE (127 DEG) SIZE 3.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 6021-3535

Device Problems Degraded (1153); Insufficient Information (3190)

Patient Problems Inflammation (1932); Injury (2348); Reaction (2414); No Code Available (3191)

Event Date 04/13/2015

Event Type  Injury  

Event Description

It was reported that the patient had a revision of the failed left hip.Stem, liner, head were revised and cup was retained.

Manufacturer Narrative

Additional devices listed in this report: cat # 6260-9-244, lot # unknown, description: v40 cocr lfit head 44mm/+4.Unknown 44 liner.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

The device was not returned per hospital policy.An event regarding revision for an unspecified reason involving an accolade stem was reported.The event was not confirmed.Method & results: the device was not returned for evaluation.Medical records were not provided.Dhr review was satisfactory.Chr confirmed that there were no other similar reported events for the lot.Conclusions: revision surgery to replace the stem, liner and head components was performed for an unspecified reason.The reported event cannot be confirmed with the limited information provided.Further information such as device evaluation, x-rays, operative reports, 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, this investigation will be reopened.

Event Description

It was reported that the patient had a revision of the failed left hip.Stem, liner, head were revised and cup was retained.

Manufacturer Narrative

An event regarding wear involving an accolade stem was reported.The event was not confirmed.Method & results: -product evaluation and results: not performed as no products were returned for examination.-clinician review: a review of the provided medical records and/or x-rays by a clinical consultant indicated: " on april 16, 2008 he underwent a primary left total hip arthroplasty with a diagnosis of left hip osteoarthritis.On november 17, 2010 a primary right total hip arthroplasty was performed for a diagnosis of osteoarthritis of the right hip.The operative report describes general anesthesia, an anterior approach, and the use of exactech implants.On may 20, 2013 plasma chromium was noted to be 1.1, which was normal (normal being 0.1 to 2.1), and cobalt was elevated at 3.4 (normal being 0 to 0.9).Subsequent values on august 29, 2013 were 1.4 chromium and 4.5 for cobalt, on august 28, 2014 chromium was 2.0 and cobalt was 5.8 and on december 3, 2014 chromium was 2.7 and cobalt was 5.7 and the urine cobalt and chromium levels were noted to be elevated.On december 16, 2014 the plan was revision of the left total hip arthroplasty and on april 8, 2015 a history and physical states, " pain in the hip and has elevated cobalt and chromium from a recalled stryker hip implant".On april 13, 2015 a revision of the left total hip arthroplasty, femur, and acetabular screws and liner, and abductor tendon repair was performed for a diagnosis of "failed left tha with metallosis and abductor tendon disruption".The operative report describes general anesthesia and notes, "pain in the setting of a recalled component".The findings at surgery were , "no significant osteolysis.Avulsion of abductor off greater trochanter.Visible metallosis.Morse taper/trunnion junction with metal debris within head and around the base of the trunnion".An office visit of may 26, 2015 notes, "no pain.Doing well".X-ray printouts available for review include an undated ap of the pelvis and lateral of the left hip demonstrating uncemented bilateral total hip arthoplasties, the left having a larger prosthetic head and two screws in the acetabulum.The hips are reduced and in nominal position.Multiple views of the left hip, all undated, include one ap portable, post-operative, and are unchanged from the previous description, and there are multiple undated x-rays of the left hip demonstrating the monoblock revision, long-stem uncemented, with a small head.The hip is reduced and the same acetabulum is present with the screws having been removed.Mitek anchors are noted in the greater trochanter.There is no examination of the explanted components.No mri images are available for review and the report only states "suggestive of altr".The modest elevation of cobalt and chromium ions in a patient with long-standing bilateral total hips in not diagnostic of pathology.Surgical histopathology is not diagnostic of altr, metallosis or pseudotumor.Based upon the information available for review, no determination can be made regarding the cause of this clinical situation described regarding the left total hip arthroplasty in this case." -product history review: review of the product history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for this lot.Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.A review of the medical review indicated " there is no examination of the explanted components.No mri images are available for review and the report only states "suggestive of altr".The modest elevation of cobalt and chromium ions in a patient with long-standing bilateral total hips in not diagnostic of pathology.Surgical histopathology is not diagnostic of altr, metallosis or pseudotumor.Based upon the information available for review, no determination can be made regarding the cause of this clinical situation described regarding the left total hip arthroplasty in this case." if the devices and additional information are received, this investigation will be reopened and re-evaluated.

Event Description

It was reported that the patient had a revision of the failed left hip.Stem, liner, head were revised and cup was retained.Update: "on april 8, 2015 a history and physical states, pain in the hip and has elevated cobalt and chromium from a recalled stryker hip implant.On april 13, 2015 a revision of the left total hip arthroplasty, femur, and acetabular screws and liner, and abductor tendon repair was performed for a diagnosis of failed left tha with metallosis and abductor tendon disruption.The operative report describes general anesthesia and notes, "pain in the setting of a recalled component." the findings at surgery were , "no significant osteolysis.Avulsion of abductor off greater trochanter.Visible metallosis.Morse taper/trunnion junction with metal debris within head and around the base of the trunnion.".

• Brand Name: ACCOLADE (127 DEG) SIZE 3.5 ACCOLADE (127 DEG) SIZE 3.5
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 4763439
• MDR Text Key: 18544944
• Report Number: 0002249697-2015-01484
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K994366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2012
• Device Catalogue Number: 6021-3535
• Device Lot Number: 24658405
• Other Device ID Number: STERILE LOT: 0711GM1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 186