MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #3 9MM; IMPLANT

Catalog Number 5531G309

Device Problems Use of Device Problem (1670); Device Contamination with Chemical or Other Material (2944); Device Handling Problem (3265)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/14/2015

Event Type  malfunction  

Manufacturer Narrative

When completed, the evaluation summary will be submitted in a supplemental report.

Event Description

It has been reported by the customer that during a primary knee surgery when the surgeon going to implant the polyethylene, he noticed that it had spots.The surgeon decided to implant another one that was available in the theatre.

Manufacturer Narrative

An event regarding damage involving a triathlon insert was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection of the returned component indicates these marks and indentations appear to have been caused by some form of obstruction in the joint space that the insert made contact with during the attempted implantation.There are two prominent indentation spots on the posterior slope of the intra-condylar notch.There is evidence of extensive implantation attempts and subsequent explantation damage.Medical records received and evaluation: not performed as no medical records were provided.Device history review: dhr review for the reported lot was satisfactory.Complaint history review: chr review for the reported lot confirmed that there are no other similar events reported.Conclusions: based on the visual inspection of the returned component, the marks and indentations appear to have been caused by some form of obstruction in the joint space that the insert made contact with during the attempted implantation.There are two prominent indentation spots on the posterior slope of the intra-condylar notch.There is evidence of extensive implantation attempts.No further investigation for this event is required at this time.

Event Description

It has been reported by the customer that during a primary knee surgery when the surgeon going to implant the polyethylene, he noticed that it had spots.The surgeon decided to implant another one that was available in the theatre.

• Brand Name: X3 TRIATHLON CS INSERT #3 9MM
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5001593
• MDR Text Key: 24206624
• Report Number: 0002249697-2015-02629
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 07/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 5531G309
• Device Lot Number: LEC970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2015
• 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