MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE STEM; HIP IMPLANT

Catalog Number UNK_REC

Device Problems Corroded (1131); Material Discolored (1170); Insufficient Information (3190)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 09/13/2016

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that the surgeon stated he was revising an accolade tmz stem.When he removed the metal head he felt there was an amount of corrosion on the taper.He revised the poly liner and felt there was significant oxidation.There appeared to be yellowing of the liner.

Manufacturer Narrative

Corrected data: the device was not returned for evaluation.An event regarding corrosion involving an unknown accolade tmzf stem was reported.The event was not confirmed.Method & results: -device evaluation and results: the device was not returned for analysis.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device details, device analysis, operative reports, x-rays, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.

Event Description

It was reported that the surgeon stated he was revising an accolade tmz stem.When he removed the metal head he felt there was an amount of corrosion on the taper.He revised the poly liner and felt there was significant oxidation.There appeared to be yellowing of the liner.

• Brand Name: UNKNOWN ACCOLADE STEM
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6013542
• MDR Text Key: 56924072
• Report Number: 0002249697-2016-03194
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/13/2016

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 Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/22/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2016
• Initial Date FDA Received: 10/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention