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

Catalog Number	5517F401
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock on with no relevant reported discrepancies.There have been no other events for the reported lot.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
When the implant was opened.It was noticed that the internal packaging damaged.
Event or Problem Description
When the implant was opened.It was noticed that the internal packaging damaged.
Additional Manufacturer Narrative
An event regarding packaging damage involving a triathlon femoral component was reported.The event was confirmed by visual inspection.Conclusion: based on the visual inspection of the returned product the investigation concluded that the packaging damage was most likely caused by incorrect/excessive handling prior to opening of the product whereby the unit carton may have been compressed and/or dropped from a height causing the damage to the carton.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 P/A CR BEADED #4L
• 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: 7357602
• Report Number: 0002249697-2018-00807
• Device Sequence Number: 13746365
• Product Code: MBH
• UDI-Device Identifier: 07613327040937
• UDI-Public: 07613327040937
• 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): 05/14/2018

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: 10/31/2022
• Device Catalogue Number: 5517F401
• Device Lot Number: CND4E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Initial Date Received by Manufacturer: 02/21/2018
• Supplement Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 03/21/2018
• Supplement Report FDA Received Date: 05/14/2018
• 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: 73 YR