MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT, CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5515-F-501

Device Problem Sticking (1597)

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

Event Date 05/12/2016

Event Type  malfunction  

Manufacturer Narrative

Only pacaging was returned, device was implanted.When completed, the investigation results will be submitted in a supplemental report.

Event Description

The #5 lt femoral component stuck in both sterile packages.Delay of surgery was 5 min.

Manufacturer Narrative

An event regarding packaging issue involving a triathlon ps fem component, cemented was reported.The event was not confirmed.Method & results: -device evaluation and results: the packaging box with a shrink wrap partially open, package insert, tyvek lid of the outer blister and the ifu were returned.The implant, tyvek lid of the inner blister and the foam was not returned.However, there is evidence that there was a seal in the inner and outer blisters.The packaging box and outer sterile packaging looks remarkable.The inner sterile packaging looks as if it was pushed inside out.-medical records received and evaluation: not performed as medical records were not provided for review.-device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.-complaint history review: no other events were reported for the lot indicated.Conclusions: the exact cause of the event could not be determined because the packaging was returned without the implant.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.

Event Description

The #5 lt femoral component stuck in both sterile packages.Delay of surgery was 5 min.

• Brand Name: TRIATHLON PS FEM COMPONENT, CEMENTED
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5710091
• MDR Text Key: 48047109
• Report Number: 0002249697-2016-01861
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 5515-F-501
• Device Lot Number: UIDYD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2016
• 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: 77 YR
• Patient Weight: 76