MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #3 R-CEM; IMPLANT

Catalog Number 5510F302

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 07/29/2015

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.Device not returned to the manufacturer.

Event Description

The head of clinical investigations has reported that a patient underwent surgery for a left knee replacement on (b)(6) 2015.The customer reported that during surgery, a right femoral component was allegedly implanted instead of a left.The customer has reported that the event was noticed by the theatre staff when they were entering the data on the njr (national joint registry).The customer has reported that initial investigations at the customer site have identified that all necessary steps were taken on site and that the reported component was viewed by the scrub nurse and the consultant performing the surgery.The customer has reported that they are not blaming the product and that they believe that this was human error; however, they felt a responsibility to report their experience.The customer has further reported that the surgeon is currently not planning on removing the component unless the patient suffers any discomfort or pain.The customer has advised that they will endeavor to provide post operative x-rays at the earliest opportunity.

Manufacturer Narrative

An event regarding incorrect selection of a triathlon femoral component.Medical review indicated that human error by the surgeon through not recognizing a right/left error in choice of triathlon femoral component at the time of implantation resulting in implantation of a right side femoral component in the patient¿s left knee.Based on the provided information it has been determined that this event is associated with an off label application.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

The head of clinical investigations has reported that a patient underwent surgery for a left knee replacement on (b)(6) 2015.The customer reported that during surgery a right femoral component was allegedly implanted instead of a left.The customer has reported that the event was noticed by the theatre staff when they were entering the data on the njr (national joint registry).The customer has reported that initial investigations at the customer site have identified that all necessary steps were taken on site and that the reported component was viewed by the scrub nurse and the consultant performing the surgery.The customer has reported that they are not blaming the product and that they believe that this was human error; however, they felt a responsibility to report their experience.The customer has further reported that the surgeon is currently not planning on removing the component unless the patient suffers any discomfort or pain.The customer has advised that they will endeavor to provide post operative x-rays at the earliest opportunity.

• Brand Name: TRIATHLON CR FEM COMP #3 R-CEM
• Type of Device: IMPLANT
• 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: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5042142
• MDR Text Key: 25290031
• Report Number: 0002249697-2015-02859
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 08/04/2015

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: 05/31/2020
• Device Catalogue Number: 5510F302
• Device Lot Number: AFC7J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2015
• 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: 75 YR