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

Catalog Number	5510F702
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock on 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 during a primary tka procedure on patient's right knee, a triathlon cemented femur was opened.The outer packaging was intact but the inner plastic packaging was broken.The surgeon refused to use the implant as its sterility could not be assured.A replacement implant was procured in the time it took to mix the cement - as a result, there was no surgical delay and no adverse affect to the patient.The procedure was completed successfully.
Additional Manufacturer Narrative
An event regarding packaging damage involving a triathlon femoral component was reported.The event was confirmed through visual inspection.Device evaluation and results: based on the visual inspection of the returned packaging it appears that this component packaging may have been compressed and/or dropped from a height causing damage to the carton and outer blister.Medical records received and evaluation: not performed as the event is related to a packaging issue.Device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the investigation concluded that the packaging damage was most likely caused by incorrect handling prior to the opening packaging whereby the carton may have been compressed and/or dropped from a height causing the damage to the carton.No further investigation for this event is required at this time.
Event or Problem Description
It was reported that during a primary tka procedure on patient's right knee, a triathlon cemented femur was opened.The outer packaging was intact but the inner plastic packaging was broken.The surgeon refused to use the implant as its sterility could not be assured.A replacement implant was procured in the time it took to mix the cement - as a result, there was no surgical delay and no adverse affect to the patient.The procedure was completed successfully.

• Brand Name: TRIATHLON CR FEM COMP #7 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: 6827383
• Report Number: 0002249697-2017-02628
• Device Sequence Number: 58643
• Product Code: MBH
• UDI-Device Identifier: 07613327040357
• UDI-Public: 07613327040357
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/31/2017

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: 04/10/2022
• Device Catalogue Number: 5510F702
• Device Lot Number: B694P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Initial Date Received by Manufacturer: 08/02/2017
• Supplement Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 08/29/2017
• Supplement Report FDA Received Date: 10/31/2017
• 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: 55 YR