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-301
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that during a primary left tka, outer blister of the femoral component was opened and what appeared to be a hair was on the tyvek of the inner blister.Due to sterility concerns, surgeon elected not to use the implant before it entered the field.Another implant was immediately available and rep reported that no surgical delay was caused.Rep was present at the time of discovery and witnessed the implant opened.
Additional Manufacturer Narrative
Conclusions: the investigation concluded the returned packaging to be nonconforming.Visual inspection of the returned product confirmed a small piece of hair on the top of the inner tyvek seal near the edge of the outer blister.Nc was raised to investigate the confirmed issue.
Event or Problem Description
It was reported that during a primary left tka, outer blister of the femoral component was opened and what appeared to be a hair was on the tyvek of the inner blister.Due to sterility concerns, surgeon elected not to use the implant before it entered the field.Another implant was immediately available and rep reported that no surgical delay was caused.Rep was present at the time of discovery and witnessed the implant opened.

• 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: 7338969
• Report Number: 0002249697-2018-00744
• Device Sequence Number: 852186
• Product Code: MBH
• UDI-Device Identifier: 07613327050356
• UDI-Public: 07613327050356
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 07/17/2018

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: 12/31/2022
• Device Catalogue Number: 5515-F-301
• Device Lot Number: BAA3TBAH4D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Initial Date Received by Manufacturer: 02/15/2018
• Supplement Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 03/14/2018
• Supplement Report FDA Received Date: 07/17/2018
• 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
• Patient Age: 71 YR
• Patient Weight: 82