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

Catalog Number	5510F702
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2018
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 reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.
Event or Problem Description
Primary procedure, right knee.It was reported that in opening the outer sterile packaging, the rim of the plastic packaging broke off with the tyvek.The inner packaging was intact, but due to sterility concerns, the implant was not used and was disposed.Another implant was immediately available, and rep confirmed there was no surgical delay whatsoever.Rep was present in the o.R.And witnessed the event.
Additional Manufacturer Narrative
An event regarding packaging damage involving a triathlon femoral component was reported.The event was confirmed by the photograph.Method & results: device evaluation and results: no product was returned for evaluation.One photograph was provided.The photograph shows the outer blister with the tyvek lid removed.One side flange is broken away/fractured from the outer blister.The broken portion of the outer blister remains attached to the tyvek lid.There is evidence of a good seal on the outer blister.There was also a video provided.The video is of poor quality but shows the unit carton complete with shrink wrap.Medical records received and evaluation: 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 attached photograph 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.Product surveillance will continue to monitor for trends.
Event or Problem Description
Primary procedure, right knee.It was reported that in opening the outer sterile packaging, the rim of the plastic packaging broke off with the tyvek.The inner packaging was intact, but due to sterility concerns, the implant was not used and was disposed.Another implant was immediately available, and rep confirmed there was no surgical delay whatsoever.Rep was present in the operating room and witnessed the event.

• Brand Name: TRIATHLON CR FEM COMP #7 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: 7435292
• Report Number: 0002249697-2018-01145
• Device Sequence Number: 196179
• Product Code: MBH
• UDI-Device Identifier: 07613327040357
• UDI-Public: 07613327040357
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 05/16/2018

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: 12/31/2021
• Device Catalogue Number: 5510F702
• Device Lot Number: BCJ6A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2018
• Supplement Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 04/16/2018
• Supplement Report FDA Received Date: 05/16/2018
• 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: 63 YR