MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #5 R-CEM; IMPLANT

Catalog Number 5510F502

Device Problems Delivered as Unsterile Product (1421); Device Packaging Compromised (2916)

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

Event Date 07/14/2014

Event Type  malfunction  

Event Description

It was reported that during primary surgery of right knee when the package was open the sterile barrier was found to be broken.Doctor did not use implant because package was compromised.He then used a back up implant, no delay in surgery.

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding packaging damage involving a triathlon femoral component was reported.The event was confirmed.Based on the visual inspection of the returned product it appears that this component packaging was subjected to excessive handling whereby the packaging appears to have been compressed to the extent that the outer blister cracked under compressive force.Dhr review for the reported lot determined that the device was manufactured and packed to specification.Chr review determined that there were no similar events reported for the lot.The investigation concluded that the packaging damage was caused by excessive incorrect handling.No further investigation for this event is possible at this time.

Event Description

It was reported that during primary surgery of right knee when the package was open the sterile barrier was found to be broken.Doctor did not use implant because package was compromised.He then used a back up implant, no delay in surgery.

• Brand Name: TRIATHLON CR FEM COMP #5 R-CEM
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: niku kasmai ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3981712
• MDR Text Key: 4750870
• Report Number: 0002249697-2014-02994
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040267
• 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: 07/14/2014

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: 11/30/2018
• Device Catalogue Number: 5510F502
• Device Lot Number: EFXEX
• Other Device ID Number: STERILE LOT# PB125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2014
• Initial Date FDA Received: 08/05/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2013
• 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: 67 YR