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

Catalog Number	5510F602
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An event regarding pack damage involving a triathlon femoral component was reported.The event was confirmed by photographic review.Method & results: device evaluation and results: the reported device was not returned however a photograph was provided for review.The photograph shows an outer blister with an unremarkable femoral component placed inside.One side flange is broken away from the outer blister, there is evidence of a good seal on the three remaining sides of the outer blister.No images were provided of the inner blister or outer carton.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: the reported device was not returned however a photograph was provided for review.The photograph shows an outer blister with an unremarkable femoral component placed inside.One side flange is broken away from the outer blister, there is evidence of a good seal on the three remaining sides of the outer blister.No images were provided of the inner blister or outer carton.While we could confirm the issue based on the images provided, we cannot determine the state of the packaging when it arrived to the hospital and hence,the exact cause of the event could not be determined because insufficient information was provided.Additional information including return of the device and all packaging components are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Actual device not returned; device photo provided for evaluation.
Event or Problem Description
As reported: "the femur would not exit from the outer packaging.The inner packaging was stuck against the broken piece of the outer packaging.The femur could not properly leave the packaging without questioning the sterility of the product.".

• Brand Name: TRIATHLON CR FEM COMP #6 R-CEM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8444589
• Report Number: 0002249697-2019-01421
• Device Sequence Number: 429068
• Product Code: MBH
• UDI-Device Identifier: 07613327040326
• UDI-Public: 07613327040326
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Report Date (Section B): 03/22/2019

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: 08/31/2023
• Device Catalogue Number: 5510F602
• Device Lot Number: D9C3P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 03/22/2019
• 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