MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #6 R-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5510F602
Medical Device Problem Codes	Difficult to Open or Remove Packaging Material (2922); Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2018
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 relevant reported discrepancies.There have been no other events for the reported lot.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.
Event or Problem Description
Primary procedure, right knee.Rep was present for the procedure and personally witnessed the event.It was reported that on opening the outer sterile blister for the device, part of the plastic lip broke off of the plastic tray and came up with the tyvek.After opening the inner blister, the device was too tightly nested in the packaging to remove easily.The device was ultimately not used as the tech's glove came in contact with the rep's hand when both were trying to remove the device together and there were concerns about the sterility of the device.Another device was obtained and used without event.There was no surgical delay as a different part of the procedure was being performed during the event.The outer box was disposed of before the rep.Could take any pictures of it.
Event or Problem Description
Primary procedure, right knee.Rep was present for the procedure and personally witnessed the event.It was reported that on opening the outer sterile blister for the device, part of the plastic lip broke off of the plastic tray and came up with the tyvek.After opening the inner blister, the device was too tightly nested in the packaging to remove easily.The device was ultimately not used as the tech's glove came in contact with the rep's hand when both were trying to remove the device together and there were concerns about the sterility of the device.Another device was obtained and used without event.There was no surgical delay as a different part of the procedure was being performed during the event.The outer box was disposed of before the rep.Could take any pictures of it.
Additional Manufacturer Narrative
An event regarding a packaging issue involving a triathlon femoral component was reported.The event was not confirmed.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including product return and/or pictures and operative notes are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON CR FEM COMP #6 R-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: 7548411
• Report Number: 0002249697-2018-01597
• Device Sequence Number: 13511286
• Product Code: MBH
• UDI-Device Identifier: 07613327040326
• UDI-Public: 07613327040326
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/23/2018

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: 11/30/2022
• Device Catalogue Number: 5510F602
• Device Lot Number: C9D7C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 05/29/2018
• Supplement Report FDA Received Date: 07/23/2018
• 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: 69 YR