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-602

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 05/06/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Surgical tech was unable to maintain sterility of implant in sterile packaging.

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: the packaging box with a shrink wrap partially open, package insert and the implant were returned.The tyvek lid of the inner and outer blister were not returned and so does the foam.However, there is evidence that there was a seal in the inner and outer blisters.The implant looks unremarkable.-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.-complaint history review: there have been no similar previous reported events for this lot id.Conclusions: the reported event could not be confirmed as the condition of the lids for both the inner and outer blisters were not returned.There is evidence of seal on both blisters.The packaging box looks intact and no signs of damage were observed.If additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Surgical tech was unable to maintain sterility of implant in sterile packaging.

• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5693132
• MDR Text Key: 47305373
• Report Number: 0002249697-2016-01780
• 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: 05/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2016
• 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-602
• Device Lot Number: UTUYD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2016
• 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