MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE C CS 127 NK; HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES

Catalog Number	6057-0230D
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Primary procedure, left hip.It was reported that the nurse brought the device to the surgeon.The surgeon opened the device and reported there was foreign material stuck to the device that appeared to be either glue or styrofoam.Due to sterility concerns, the surgeon refused to implant the device.Rep retrieved another device for the surgeon to use with a surgical delay of under 5 minutes.
Additional Manufacturer Narrative
An event regarding foreign matter involving an accolade stem was reported.The event was confirmed by product inspection.Method & results: -product evaluation and results: a material analysis has been performed and the report concluded, ¿debris was observed on the stem.Ftir analysis the assayed spectrum of the debris could not be matched to the available library spectrum.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.¿ -product history review: a device history review confirmed all devices accepted into finished goods conformed to specification.-complaint history review: no other events were reported for the lot indicated.Conclusions: the investigation confirmed the reported event however, the root cause could not be determined.A material analysis report concluded, "debris was observed on the stem.Ftir analysis the assayed spectrum of the debris could not be matched to the available library spectrum.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.¿ furthermore, consultation with packaging operation sme¿s noted that based on the packaging design, device router and their procedure for visual checks this device was manufactured and packaged to specification and the alleged event would not have occurred.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Primary procedure, left hip.It was reported that the nurse brought the device to the surgeon.The surgeon opened the device and reported there was foreign material stuck to the device that appeared to be either glue or styrofoam.Due to sterility concerns, the surgeon refused to implant the device.Rep retrieved another device for the surgeon to use with a surgical delay of under 5 minutes.

• Brand Name: ACCOLADE C CS 127 NK
• Common Device Name: HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8086856
• Report Number: 0002249697-2018-03759
• Device Sequence Number: 295111
• Product Code: LPH
• UDI-Device Identifier: 07613327020663
• UDI-Public: 07613327020663
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/30/2021
• Device Catalogue Number: 6057-0230D
• Device Lot Number: Y58L9Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 03/20/2019
• 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: Other