MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5532-G-509

Device Problems Material Discolored (1170); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2015

Event Type  malfunction  

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Event Description

The package had what looked like a dried liquid stain on the tyvek seal.

Manufacturer Narrative

An event regarding compromised packaging involving a triathlon ps x3 tibial insert was reported.The event was not confirmed.Method and results: device evaluation: the returned device confirmed the event as the (b)(6) of the outer blister had discoloration, along with the outer box.Clinician review: not performed as medical records were not received for review with a clinical consultant.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.-omplaint history review: there have been no similar previous reported events for this lot id.Conclusions: visual inspection of the returned device indicated a corner of the outer tyvek lid was discolored however, root cause could not be determined.The outer box showed signs of discoloration along one of the corners.Upon opening the box, it was noted that the stain on the outer blister aligned with the location of the stain on the outer box.The outer blister was discolored along the corner of the blister.The inner (b)(6) was unremarkable.

Event Description

The package had what looked like a dried liquid stain on the (b)(6) seal.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5315946
• MDR Text Key: 34739571
• Report Number: 0002249697-2015-04427
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 5532-G-509
• Device Lot Number: MMPK6H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2013
• 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