MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #6L; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number	5517F601
Medical Device Problem Codes	Fitting Problem (2183); Device Operates Differently Than Expected (2913); Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock on with 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 a press fit left femur had an improper fit.Surgeon re-cut and still could not get it seated.Surgeon implanted a cemented femur instead.There was a 45 minute surgical delay but no adverse consequence to patient.Rep stated no additional anesthesia was administered.
Additional Manufacturer Narrative
An event regarding size/fit (press-fit) issue involving a triathlon femoral component was reported.The event was not confirmed.Device evaluation and results: multi directional scratches on the bearing surface of the femoral component are consistent with attempted implantation, explantation damage and subsequent post explantation/handling damage.The internal fixation surface appears unremarkable.Dimensional analysis confirms the device is within specification.Medical records received and evaluation: not performed as medical records were not provided.Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there were no other similar events for the referenced lot.Conclusions: the results of the investigation indicated that the device was visually and dimensionally within specifications.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.
Event or Problem Description
It was reported that a press fit left femur had an improper fit.Surgeon re-cut and still could not get it seated.Surgeon implanted a cemented femur instead.There was a 45 minute surgical delay but no adverse consequence to patient.Rep stated no additional anaesthesia was administered.

• Brand Name: TRIATHLON P/A CR BEADED #6L
• 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: 6747051
• Report Number: 0002249697-2017-02304
• Device Sequence Number: 881991
• Product Code: MBH
• UDI-Device Identifier: 07613327040975
• UDI-Public: 07613327040975
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/28/2017

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: 11/16/2021
• Device Catalogue Number: 5517F601
• Device Lot Number: BL66J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Initial Date Received by Manufacturer: 06/28/2017
• Supplement Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 07/27/2017
• Supplement Report FDA Received Date: 09/29/2017
• 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