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

Catalog Number	5517F701
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2018
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 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
Opened an implant in theatre and the implant packaging was broken - as we handed the implant to the scrub nurse we then realized it had been cracked.
Additional Manufacturer Narrative
Additional information: product available to stryker.An event regarding packaging damage involving a triathlon femoral component was reported.The event was confirmed by images provided of the damaged flange.On the unit carton, indentation lines are visible on the sides and flap of the opening end on the inside and the outside.The flap is peeling and a slit has gone across the opening end.The outer blister was returned with the tyvek lid removed.One side flange/lip of the outer blister was broken off the outer blister and remains attached to the tyvek lid.There is evidence of a good seal on the outer blister.The device and the inner blister was not returned.Medical records received and evaluation: not performed as the event is related to a packaging issue.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.Review of the manufacturing records indicated all devices were manufactured and accepted into final stock with no reported discrepancies.On the unit carton, indentation lines are visible on the sides and flap of the opening end on the inside and the outside.The flap is peeling and a slit has gone across the opening end.The outer blister was returned with the tyvek lid removed.One side flange/lip of the outer blister was broken off the outer blister and remains attached to the tyvek lid.There is evidence of a good seal on the outer blister.The device and the inner blister was not returned.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, however this cannot be confirmed.No further investigation for this event is required at this time.
Event or Problem Description
Opened an implant in theatre and the implant packaging was broken - as we handed the implant to the scrub nurse we then realized it had been cracked.

• Brand Name: TRIATHLON P/A CR BEADED #7L
• 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: 7304411
• Report Number: 0002249697-2018-00579
• Device Sequence Number: 1328417
• Product Code: MBH
• UDI-Device Identifier: 07613327041002
• UDI-Public: 07613327041002
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 04/18/2018

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: 12/31/2021
• Device Catalogue Number: 5517F701
• Device Lot Number: BPE9R
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 02/28/2018
• Supplement Report FDA Received Date: 04/18/2018
• 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: 80 YR
• Patient Weight: 98