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

Model Number	6481-1-110
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	04/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem 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".
Additional 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 or Problem 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
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6579819
• Report Number: 0002249697-2017-01592
• Device Sequence Number: 18867671
• Product Code: KRO
• UDI-Device Identifier: 07613327045130
• UDI-Public: (01)07613327045130(11)151013(17)211031(10)ALK9R
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K002552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2017

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: 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
• Initial Date Received by Manufacturer: 04/24/2017
• Supplement Date Received by Manufacturer: 07/07/2017
• Initial Report FDA Received Date: 05/19/2017
• Supplement Report FDA Received Date: 08/02/2017
• 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
• Patient Age: 66 YR