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 Codes	Difficult to Remove (1528); Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate the devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that during a procedure on patient's right knee, the implant could not be removed from the packaging as it was wedged in too tightly.A replacement implant was immediately available for use.There was no surgical delay and no harm to the patient.
Additional Manufacturer Narrative
Additional information: device evaluated by mfg.An event regarding a packaging issue involving a triathlon femoral component was reported.The event was confirmed.The device was returned with its packaging box, implant stickers, and the inner blister containing the implant.Inspection of the returned packaging confirms the event that the implant was wedged in tightly and had difficulty removing the implant from the blister.Apart from this the implant looks unremarkable.No medical records were received for review with a clinical consultant.No adverse consequences to the patient were noted.Review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.Conclusions: the investigation concluded that an nc has been raised to investigate the event.The nc was initiated to address a nonconformance wherein the implant could not be removed from the packaging as it was wedged in too tightly.
Event or Problem Description
It was reported that during a procedure on patient's right knee, the implant could not be removed from the packaging as it was wedged in too tightly.A replacement implant was immediately available for use.There was no surgical delay and no harm to the patient.

• 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: 7027658
• Report Number: 0002249697-2017-03283
• Device Sequence Number: 11025725
• Product Code: MBH
• UDI-Device Identifier: 07613327050400
• UDI-Public: 07613327050400
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2018

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: 06/23/2022
• Device Catalogue Number: 5515-F-502
• Device Lot Number: AOB4OA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Initial Date Received by Manufacturer: 10/16/2017
• Supplement Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 11/14/2017
• Supplement Report FDA Received Date: 01/04/2018
• 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