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

Catalog Number	5515F701
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicates 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 while performing a primary procedure on patient's left knee, a triathlon femoral component was prepared.The inner packaging was compromised.Surgeon refused to implant component due to sterility concerns.A replacement implant was immediately available and used.Rep reported that the procedure was completed successfully with no surgical delays and no adverse effects to the patient.
Additional Manufacturer Narrative
An event regarding packaging damage involving a triathlon femoral component was reported.The event was confirmed by visual inspection.Device evaluation and results: the unit carton without its shrink wrap was returned for analysis.There is compression and indentation lines visible throughout the carton.The outer blister was returned with the tyvek lid completely removed.The outer blister tyvek lid was not returned.One side flange was broken/fractured away from the outer blister.There is evidence of a good seal on the three remaining sides of the outer blister.The inner blister was returned unopened.The inner blister was opened as part of the evaluation.There is evidence of a good seal on all four sides.The femoral component within the pack was unremarkable.Medical records received and evaluation: not performed as the event is related to a packaging issue and no adverse consequences to the patient were reported.Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.The investigation concluded that the packaging damage was most likely caused by excessive/incorrect handling prior to the opening packaging whereby the carton may have been compressed and/or dropped from a height causing the damage to the carton.No further investigation for this event is required at this time.
Event or Problem Description
It was reported that while performing a primary procedure on patient's left knee, a triathlon femoral component was prepared.The inner packaging was compromised.Surgeon refused to implant component due to sterility concerns.A replacement implant was immediately available and used.Rep reported that the procedure was completed successfully with no surgical delays and no adverse effects to the patient.

• Brand Name: TRIATHLON PS FEM COMP #7L-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: 6858208
• Report Number: 0002249697-2017-02734
• Device Sequence Number: 636384
• Product Code: MBH
• UDI-Device Identifier: 07613327040722
• UDI-Public: 07613327040722
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 11/09/2017

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: 05/11/2021
• Device Catalogue Number: 5515F701
• Device Lot Number: AYY3J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 09/12/2017
• Supplement Report FDA Received Date: 11/09/2017
• 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
• Patient Age: 60 YR