MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #5 L-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5510F501

Device Problems Device Contamination with Chemical or Other Material (2944); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/21/2016

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device remained implanted in the patient and was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

It is reported that obvious stain on the femoral component surface (triathlon cr #5, lt) was found just after opening the femoral component from the original package during the preparation of the operation.It is informed that scrub nurse tried to remove the stain with alcohol but it was not removed.Since there was no replacement, it is informed that the stained femoral component was implanted but the surgeon complained and doubted about the product quality.Adverse event has not been reported yet but the surgeon has been worried about adverse impact in regard to poly wear by scratch.

Manufacturer Narrative

Reported event: an event regarding a stain or scratch involving a triathlon femoral component was reported.The event was not confirmed.Method & results: -device evaluation and results: one poor quality photograph of the reported "stain" or "scratch" was provided.It is not possible to confirm a stain or a scratch as reported in the event description due to the poor quality of the photograph and the reflection of what appears to be strong operating theatre lighting on the polished surface of the part.-medical records received and evaluation: not performed as medical records were not provided.-device history review: dhr review was satisfactory.-complaint history review: chr review confirmed that there were no other similar reported events for the lot.Conclusions: the photograph provided by the customer was reviewed by the femoral manufacturing cell.The manufacturing cell concluded that: "a review has been completed of the image below and it cannot be confirmed that a defect is present.The image is poor and difficult to distinguish the area highlighted as a defect." the reported stain or scratch have not been confirmed.It is noted that the component was implanted therefore no further evaluation is possible.Should the device or additional information become available, this investigation will be reopened.

Event Description

It is reported that obvious stain on the femoral component surface(triathlon cr #5, lt) was found just after opening the femoral component from the original package during the preparation of the operation.It is informed that scrub nurse tried to remove the stain with alcohol but it was not removed.Since there was no replacement, it is informed that the stained femoral component was implanted but the surgeon complained and doubted about the product quality.Adverse event has not been reported yet but the surgeon has been worried about adverse impact in regard to poly wear by scratch.

• Brand Name: TRIATHLON CR FEM COMP #5 L-CEM
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5661371
• MDR Text Key: 45434523
• Report Number: 0002249697-2016-01631
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 5510F501
• Device Lot Number: AJB6H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2016
• Initial Date FDA Received: 05/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2015
• 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