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-402
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Nurse opened implant box and noticed hair on the inside of box.Implant was never opened on to the sterile field.
Additional Manufacturer Narrative
Reported event: an event regarding a hair in the inner blister pack involving a trident femoral component was reported.The event was confirmed.Method & results: -device evaluation and results: the device and packaging materials were received and visual inspection confirmed the event.The hair was taped on top of the inner blister.-medical records received and evaluation: not performed as it was reported that there were no adverse consequences nor medical intervention.-device history review: there were no reported discrepancies.-complaint history review: there have been no other events for the lot referenced.Conclusions: the investigation concluded the returned packaging to be nonconforming.Visual inspection of the returned product confirmed a small piece hair in between the outer and inner blister.Nc was raised (b)(6) 2017 to investigate the confirmed issue.This event is considered to be an isolated incident.It was concluded that the stray hair had no effect on the quality, functionality, or sterility of the implant.The inner sterile barrier was not impacted as the representative stated that the hair was found outside of the inner blister.The outer blister sealing operation is the only opportunity for a final inspection of the inner tyvek before the part is sealed.It would then be ultimately inspected at hospital.
Event or Problem Description
Nurse opened implant box and noticed hair on the inside of box.Implant was never opened on to the sterile field.Update: sales rep confirmed the hair was found between the outer and inner blister.There was no surgical delay as an additional implant was available.

• 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: 6517193
• Report Number: 0002249697-2017-01351
• Device Sequence Number: 1642061
• Product Code: MBH
• UDI-Device Identifier: 07613327050370
• UDI-Public: (01)07613327050370(11)170302(17)220331(10)ABS7ZD
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2017

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: 03/31/2022
• Device Catalogue Number: 5515-F-402
• Device Lot Number: ABS7ZD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/28/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2017
• Supplement Report FDA Received Date: 06/05/2017
• 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