MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRH KNEE FEM S LFT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 64811110

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Information (3190)

Event Date 04/24/2017

Event Type  malfunction  

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.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.

Event Description

During a revision knee when it was time to open the implants the surgeon and rep in the room noticed a powder like substance on the femoral implant.They then opened two stems and both stems had the same residue.A second femoral implant was rushed to the hospital and once again was found to have the same residue on the implant.The surgeon was obviously very upset by this and had to soak the implants in betadine before finally implanting them as there were no other alternatives.These implants all came from "national loaners".

• Brand Name: MRH KNEE FEM S LFT
• 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: sarah smelko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6583532
• MDR Text Key: 75720067
• Report Number: 0002249697-2017-01602
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07613327045130
• UDI-Public: (01)07613327045130(11)161130(17)211130(10)BAP6N
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 64811110
• Device Lot Number: BAP6N
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2016
• 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): Other
• Patient Age: 66 YR