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-502

Device Problems Contamination (1120); Difficult to Open or Remove Packaging Material (2922); 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 09/16/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As per sales rep, during right knee surgery when nurse opened the implant package the label got stuck to the implant.Surgeon questioned if it was contaminated and used another implant.

Manufacturer Narrative

An event regarding a packaging issue involving a triathlon femoral component was reported.The event was not confirmed.Method & results: -device evaluation and results: visual inspection of the femoral component packaging, outer blister, femoral component labeling and the femoral component was unremarkable.-medical records received and evaluation: not performed as the event is not related to patient factors.-device history review: indicates (b)(4) devices were manufactured and accepted into final stock on with no reported discrepancies.-complaint history review: there have been no other events for this lot.Conclusions: femoral component packaging (without shrink wrapping), the opened outer blister without its lid, femoral component labeling and the femoral component were returned.The inner blister with its lid was not returned.Because the outer blister lid and the inner blister with its lid were not returned, the reported event could not be confirmed.Visual inspection of the femoral component packaging, outer blister, femoral component labeling and the femoral component was unremarkable.The root cause is a known packaging issue.Packaging innovations is aware of this, and has issued a memo.It is related to a void-filling approach to sterile product packaging.Due to the infrequent nature of these complaints and the greater risk that would be presented by undersized foam, these events will not be addressed through a design change.

Event Description

As per sales rep, during right knee surgery when nurse opened the implant package the label got stuck to the implant.Surgeon questioned if it was contaminated and used another implant.

• 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: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5147181
• MDR Text Key: 28644843
• Report Number: 0002249697-2015-03346
• 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: Followup
• Report Date: 09/16/2015

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: 05/31/2020
• Device Catalogue Number: 5515-F-502
• Device Lot Number: NBOPD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/29/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/27/2015
• 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