MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #5; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5520B500

Device Problems Break (1069); Device Damaged Prior to Use (2284); Device Disinfection Or Sterilization Issue (2909); Device Packaging Compromised (2916); Packaging Problem (3007)

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

Event Date 12/12/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was noticed upon opening the outer box of a size 5 triathalon primary tibial baseplate, the inner plastic seal to the implant had been broken and the implant was not sterile.Rep informed the dr.And supplied him with a back up implant of the same size and description.

Manufacturer Narrative

Corrected data: an event regarding packaging damage involving a triathlon baseplate was reported.The event was confirmed.Method & results: device evaluation and results: one photograph was received.The photograph shows the outer blister with one side flange broken away from the outer blister.The broken side flange remains attached to the tyvek paper.Medical records received and evaluation: not performed as the event relates to a packaging issue.Device history review: indicated devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: chr review determined that there were no similar events reported for the lot.Conclusions: the exact cause of the event could not be determined because insufficient information was received.Further information such as all packaging is required to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If packaging becomes available, this investigation will be reopened.Not returned.

Event Description

It was noticed upon opening the outer box of a size 5 triathalon primary tibial baseplate, the inner plastic seal to the implant had been broken and the implant was not sterile.Rep informed the dr.And supplied him with a back up implant of the same size and description.

• Brand Name: TRIATHLON PRIM CEM FXD BPLT #5
• 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-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6235700
• MDR Text Key: 64614032
• Report Number: 0002249697-2017-00147
• Device Sequence Number: 1
• Product Code: MEH
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 5520B500
• Device Lot Number: BJH2P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2016
• 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