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 Consequences Or Impact To Patient (2199)
Date of Event	02/21/2019
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 relevant reported discrepancies.There have been no other similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available, it will be reported in a supplemental report upon completion of the investigation.Device not returned to the manufacturer.
Event or Problem Description
Nurse opened box of femur which was in perfect condition.Then went to open outer plastic to give to scrub nurse but there was a crack in plastic.We tried to get her to peel femur out of inner casing but it was too hard and became unsterile.Update: femur was not implanted, 1 minute to retrieve new femur.
Additional Manufacturer Narrative
An event regarding pack damage involving a triathlon femoral component was reported.The event was confirmed based on the images provided.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: 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 and remains attached to the tyvek.No images were provided of the inner blister or outer carton.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: 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 and remains attached to the tyvek.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.
Event or Problem Description
Nurse opened box of femur which was in perfect condition.Then went to open outer plastic to give to scrub nurse but there was a crack in plastic.We tried to get her to peel femur out of inner casing but it was too hard and became unsterile.Update: femur was not implanted, 1 minute to retrieve new 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: 8444687
• Report Number: 0002249697-2019-01422
• Device Sequence Number: 354498
• Product Code: MBH
• UDI-Device Identifier: 07613327040326
• UDI-Public: 07613327040326
• 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: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2019

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: 01/31/2023
• Device Catalogue Number: 5510F602
• Device Lot Number: DB74S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2019
• Supplement Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 05/15/2019
• 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