MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS FEM STEM W/O BODY 17X127MM PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 64853117

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2018

Event Type  malfunction  

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 events for the lot referenced. A supplemental report will be submitted upon completion of the investigation.

Event Description

Primary procedure, proximal femur. As reported: "we opened the implant box, surgical tech peeled back the protective packaging and she and the surgeon noticed white specs. On the implant immediately upon opening. The surgeon then asked for a new implant to be opened. The per implant never was removed from the [inner sterile tray], never was implanted, and never touched the patient". Rep reported there was no surgical delay in providing a second implant. Rep was present for the procedure. None of the packaging except the inner sterile tray was retained.

• Brand Name: MRS FEM STEM W/O BODY 17X127MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: joanne mahony ; ida industrial estate; carrigtwohill NA ; 214532800
• MDR Report Key: 7911788
• MDR Text Key: 121866344
• Report Number: 0002249697-2018-03075
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 64853117
• Device Lot Number: 170520C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/26/2018 Patient Sequence Number: 1