MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMP #7R-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5515F702
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2018
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 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
Due to operations mishandling of the implants, the outer package (package had been wrapped too tight, and handled too many times - causing the inner package to break within the cardboard box).The nurse along with the surgeon deemed the implant unsterile and not usable for the case.I reported to operations and my office right away, but due to the sticker of the implant in question being reported on a bill sheet - the office informed me that a report must be submitted.
Additional Manufacturer Narrative
An event regarding packaging damage involving a triathlon femoral component was reported.The event was confirmed through the photographs provided.Method & results: -device evaluation and results: the reported device was not returned however photographs were provided for review.The photographs shows an opened inner sterile blister with one flange of the blister broken off.The broken section of the blister flange remains attached to the opened tyvek lid.-medical records received and evaluation: not performed as 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.Conclusions: the reported event indicated the packaging was noted to be damaged upon opening.The reported device was not returned however photographs were provided for review.The photographs shows an opened sterile blister with one flange of the blister broken off.The broken section of the blister flange remains attached to the opened tyvek lid.Photographs of the pack carton or other packaging components were not provided or returned for evaluation, these would be required to further investigate this event.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
Due to operations mishandling of the implants, the outer package (package had been wrapped too tight, and handled too many times - causing the inner package to break within the cardboard box).The nurse along with the surgeon deemed the implant unsterile and not usable for the case.I reported to operations and my office right away, but due to the sticker of the implant in question being reported on a bill sheet - the office informed me that a report must be submitted.

• Brand Name: TRIATHLON PS FEM COMP #7R-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: 8203043
• Report Number: 0002249697-2018-04157
• Device Sequence Number: 1656725
• Product Code: MBH
• UDI-Device Identifier: 07613327040739
• UDI-Public: 07613327040739
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 03/13/2019

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: 11/30/2019
• Device Catalogue Number: 5515F702
• Device Lot Number: ELFHL
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/30/2018
• Supplement Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 03/13/2019
• 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