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

Model Number 6481-1-110

Device Problems Device Damaged Prior to Use (2284); Contamination of Device Ingredient or Reagent (2901); Device Contamination with Chemical or Other Material (2944)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 04/24/2017

Event Type  malfunction  

Manufacturer Narrative

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

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".

Manufacturer Narrative

An event regarding white residue involving a mrh femoral component was reported.The event was confirmed.Method & results: device evaluation and results: a visual inspection was carried out on the returned device a white residue was observed on the tray.A sample was taken from the tray for in-house analysis.The device was otherwise unremarkable.A material analysis was performed on the returned device which indicated that a review of modular rotating hinge knee femoral component, catalogue# 6481-1-110, lot code alk9r and inner blister plastic tray confirmed white particles on both tray and femoral.Characterisation using stereo microscopy and infrared spectroscopy confirmed particles as debris from petg inner blister tray due to mechanical abrasion with femoral component.Medical records received and evaluation: not performed as the reported device was not implanted.Device history review: the device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar reported events for the lot referenced.Conclusions: the material analysis indicated that the inner blister plastic tray confirmed white particles on both tray and femoral.Characterisation using stereo microscopy and infrared spectroscopy confirmed particles as debris from petg inner blister tray due to mechanical abrasion with femoral component.The exact cause of the event could not be determined because no other packaging was returned.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6579819
• MDR Text Key: 75723286
• Report Number: 0002249697-2017-01592
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07613327045130
• UDI-Public: (01)07613327045130(11)151013(17)211031(10)ALK9R
• 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,Followup
• Report Date: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: 6481-1-110
• Device Catalogue Number: 64811110
• Device Lot Number: ALK9R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2015
• 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