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 Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock 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 the packaging was compromised on a size 6 right cr cemented femur.
Additional Manufacturer Narrative
An event regarding pack damage involving a triathlon femoral component was reported.The event was confirmed by visual inspection of the returned product.Method & results: -device evaluation and results: one unit carton with its shrink wrap opened was returned for evaluation.Compression and indentation lines are visible on the opening end, corners and on the underside of the unit carton.The outer blister was returned with the tyvek lid removed fully.One side flange of the outer blister is broken away and remains attached to the tyvek lid.There is evidence of a good seal on the remaining sides of the outer blister.The inner blister was returned unopened inside the outer blister.For the purpose of this investigation the tyvek lid was removed from the inner blister.There is evidence of a good seal between the tyvek lid and the inner blister.The returned device appears unremarkable.-clinician review: not performed as no medical records were provided.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.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.
Event or Problem Description
It was reported that the packaging was compromised on a size 6 right cr cemented femur.

• 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: 8043151
• Report Number: 0002249697-2018-03630
• Device Sequence Number: 13750050
• Product Code: MBH
• UDI-Device Identifier: 07613327040326
• UDI-Public: 07613327040326
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2019

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: 01/31/2022
• Device Catalogue Number: 5510F602
• Device Lot Number: BYX6L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Initial Date Received by Manufacturer: 10/09/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 11/06/2018
• Supplement Report FDA Received Date: 01/07/2019
• 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