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
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	05/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
Reported the packaging was not allowing the inner packing of the femoral component to be removed from the outer packaging.
Additional Manufacturer Narrative
An event regarding packaging issue involving a triathlon ps fem component, cemented was reported.The event was confirmed.Method & results: device evaluation: the returned device confirmed the event as the tyvek of the inner blister was stuck to the tyvek of the outer blister.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: visual inspection of the returned device indicated the tyvek of the inner blister was stuck to the tyvek of the outer blister however, root cause could not be determined as the packaging team confirmed that the blisters were within specs.
Event or Problem Description
Reported the packaging was not allowing the inner packing of the femoral component to be removed from the outer packaging.

• Brand Name: TRIATHLON PS FEM COMPONENT, CEMENTED
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6653751
• Report Number: 0002249697-2017-01939
• Device Sequence Number: 10818163
• Product Code: MBH
• UDI-Device Identifier: 07613327050400
• UDI-Public: 07613327050400
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2021
• Device Catalogue Number: 5515-F-502
• Device Lot Number: V3PGD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Initial Date Received by Manufacturer: 05/23/2017
• Supplement Date Received by Manufacturer: 08/11/2017
• Initial Report FDA Received Date: 06/20/2017
• Supplement Report FDA Received Date: 09/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other