MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 5.5 ACCOLADE (127 DEG) SIZE 5.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6021-5537

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Toxicity (2333); Injury (2348); Reaction (2414)

Event Date 11/10/2016

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

Right hip revision for pain and elevated metal ion levels.Head and insert exchanged.

Manufacturer Narrative

An event regarding pain & abnormal ion levels involving an accolade stem was reported.The event was not confirmed.Method & results: device evaluation and results: intraop photo of stem shows trunnion to be intact with some black markings around the trunnion.Medical records received and evaluation: review of medical records by a consulting clinician indicated: "it is difficult to see any amount of gross material loss from the cocr head or stem trunnion in the intraoperative photograph.No other operative findings were available for review.Despite this lack of gross evidence prosthesis wear is known to result in increased circulating concentration of metal ions.In a patient with a cobalt based implant, modest increase (2-4 mcg/specimen) in urine cobalt concentration is likely to be associated with a prosthetic device in good condition.Excessive exposure is indicated when urine cobalt concentration is >5 mcg/specimen, consistent with prosthesis wear.Urine concentrations >20 mcg/specimen in a patient with a cobalt-based implant suggest significant prosthesis wear.This indirect evidence is indicative of significant wear of the cocr femoral head.Detailed material analysis of the retrieved implants would be required to investigate the degree and possible causation for this wear.Further documentation which would aid in this assessment would include: implant retrieval, operative reports, laboratory reports, operative pathology reports, pre and post op xrays from the index and revision surgeries, complete mri imaging and reports, outpatient office/clinic notes." device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: the event description indicates that the reason for revision of the hip was due to pain and high cobalt chrome levels where the head and insert were revised.Review of medical records by a consulting clinician did not confirm the pain but did confirm elevated cobalt levels for the head only.The chemical composition of the stem indicates that cobalt is not an element inherent in the devices material.The cause of the alleged pain could not be determined because insufficient information was provided.A capa trend analysis was also conducted for the alleged patient harm and concluded that pain may result from other factors not necessarily related to the device.Further documentation which would aid in this assessment would include: implant retrieval, operative reports, laboratory reports, operative pathology reports, pre and post op x-rays from the index and revision surgeries, complete mri imaging and reports, outpatient office/clinic notes.If devices and/or additional information becomes available, this investigation will be reopened.Product surveillance will continue to monitor for trends.

Event Description

Right hip revision for pain and elevated metal ion levels.Head and insert exchanged.

• Brand Name: ACCOLADE (127 DEG) SIZE 5.5 ACCOLADE (127 DEG) SIZE 5.5
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6152709
• MDR Text Key: 61665137
• Report Number: 0002249697-2016-03851
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2012
• Device Catalogue Number: 6021-5537
• Device Lot Number: 22865801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2016
• Initial Date FDA Received: 12/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 128