MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #4R; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5517F402
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the product history records indicate the devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.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.
Event or Problem Description
A distributor reported that: "before the surgery, when preparing the devices, the medical staff observed that the packaging was not damaged but the inner plastic shell is broken at the weld.Another device was used to complete the surgery".
Additional Manufacturer Narrative
Additional information: returned to manufacturer on.An event regarding packaging damage involving a triathlon femoral component was reported.The event was confirmed by visual inspection.A unit carton was returned without its shrink wrap.Indentation lines visible on the top of the unit carton at the front.The outer blister was returned with the tyvek lid partially removed.One side flange/lip of the outer blister was broken.The broken flange/lip remained attached to the tyvek lid.There is evidence of a crack on the blister.There is evidence of a good seal on the outer blister.The inner blister was returned with its tyvek lid intact.For the purpose of this investigation the tyvek lid was removed from the inner blister.There is evidence of a good seal on all four side flanges.The returned device was unremarkable.The inner blister was returned with its tyvek lid intact.For the purpose of this investigation the tyvek lid was removed from the inner blister.There is evidence of a good seal between the inner blister and the tyvek lid.The returned device appears 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.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
A distributor reported that: "before the surgery, when preparing the devices, the medical staff observed that the packaging was not damaged but the inner plastic shell is broken at the weld.Another device was used to complete the surgery".

• Brand Name: TRIATHLON P/A CR BEADED #4R
• 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: 7054256
• Report Number: 0002249697-2017-03394
• Device Sequence Number: 2036928
• Product Code: MBH
• UDI-Device Identifier: 07613327040944
• UDI-Public: 07613327040944
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2018

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: 04/20/2022
• Device Catalogue Number: 5517F402
• Device Lot Number: CBE4P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Initial Date Received by Manufacturer: 10/27/2017
• Supplement Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 01/17/2018
• 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