MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #7 L-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5510F701
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
During a total knee replacement, the surgeon was preparing to implant the triathlon knee components.The femoral implant in question was opened outside the sterile field.As the surgeon was about to accept the implant he noticed that one of inner hard plastic packaging shells was damaged and therefore he was concerned the product may be unsterile.Every other aspect of product packaging seemed intact.The rim of the plastic shell wasn¿t complete all the way around, it looks like one side snapped away at some stage.This piece of plastic wasn¿t within the packaging anywhere.Surgeon did not take the product into the sterile field as a result, and a replacement part was taken from the consignment shelf and used and the procedure was completed as normal.
Additional Manufacturer Narrative
An event regarding pack damage involving a triathlon femoral component was reported.The event was confirmed by the photograph.Method & results product evaluation and results: the reported device package was not received by pac however a photograph was provided for review.The photograph shows an opened carton, an opened outer blister and an inner blister package not opened.The tyvek layer of the outer blister package was removed and not shown in the picture.One side edge of the outer blister was fractured from the blister.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as evaluation of the device package is needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If the device package and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
During a total knee replacement, the surgeon was preparing to implant the triathlon knee components.The femoral implant in question was opened outside the sterile field.As the surgeon was about to accept the implant he noticed that one of inner hard plastic packaging shells was damaged and therefore he was concerned the product may be unsterile.Every other aspect of product packaging seemed intact.The rim of the plastic shell wasn¿t complete all the way around, it looks like one side snapped away at some stage.This piece of plastic wasn¿t within the packaging anywhere.Surgeon did not take the product into the sterile field as a result, and a replacement part was taken from the consignment shelf and used and the procedure was completed as normal.

• Brand Name: TRIATHLON CR FEM COMP #7 L-CEM
• 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: 8503555
• Report Number: 0002249697-2019-01575
• Device Sequence Number: 13508403
• Product Code: MBH
• UDI-Device Identifier: 07613327040333
• UDI-Public: 07613327040333
• Combination Product (Y/N): N
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2019

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: 05/31/2023
• Device Catalogue Number: 5510F701
• Device Lot Number: DXC3N
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 06/24/2019
• 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