MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #7; IMPLANT

Catalog Number 5520B700

Device Problem Material Discolored (1170)

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

Event Date 06/03/2014

Event Type  malfunction  

Event Description

The physician was loading the tibial tray onto the inserter when he noticed a discoloration on the tray surface.He pointed it out to me and used a lap sponge to wipe the surface of the tray.He said that there was a transfer of the mark to the lap sponge.I gave him the option of opening a new tray and he opted to do that.

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding foreign matter involving a triathlon prim cem fxd bplt #7 was reported.The event was not confirmed.Visual inspection of the returned device indicated nothing remarkable about the baseplate.A device history review indicated that the specified lot was accepted into final stock with no reported discrepancies.There have not been any other events for the specified lot.The reported event involves discoloration of the baseplate tray surface during surgery.The surgeon wiped the surface of the tray and stated that there was a transfer mark to the lap sponge.A different tray was implanted.The exact cause of the event could not be determined because not enough information was provided.Pictures of the lap sponge with the transfer mark from the baseplate and operative notes would be needed to complete a full investigation.No further investigation for this event is possible at this time.

Event Description

The physician was loading the tibial tray onto the inserter when he noticed a discoloration on the tray surface.He pointed it out to me and used a lap sponge to wipe the surface of the tray.He said that there was a transfer of the mark to the lap sponge.I gave him the option of opening a new tray and he opted to do that.

• Brand Name: TRIATHLON PRIM CEM FXD BPLT #7
• 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: niku kasmai ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3887985
• MDR Text Key: 17291393
• Report Number: 0002249697-2014-02410
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/03/2014

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: 02/28/2019
• Device Catalogue Number: 5520B700
• Device Lot Number: EHPEP
• Other Device ID Number: STERILE LOT R2117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2014
• Initial Date FDA Received: 06/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2014
• 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