MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CS INS SIZE 5 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531P513
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	06/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: tri ts baseplate size 5; cat# 5521-b-500; lot# wuhha, triathlon cr fem comp #4 r-cem; cat# 5510f402; lot# bjt6r, triathlon sym patella s36x10; cat# 5550l360; lot# ley035.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.There have been no other events for the sterile lot referenced.It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that a patient had a revision on a right total knee due to infection.The site was washed out and the poly was replaced.It was reported that there were no surgical delays.
Additional Manufacturer Narrative
An event regarding infection involving a triathlon insert was reported.The event was not confirmed.Device evaluation and results: not performed as the device was not returned.Medical records received and evaluation: not performed as no medical records were provided.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 reported lot or sterile lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as x-rays, medical records, operative notes, patient history and pathology reports are required to complete the investigation for determining root cause.A capa trend analysis was conducted for the reported failure mode and concluded infection is a known possible adverse outcome of surgery and is beyond stryker's control.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this investigation will be reopened.
Event or Problem Description
It was reported that a patient had a revision on a right total knee due to infection.The site was washed out and the poly was replaced.It was reported that there were no surgical delays.

• Brand Name: TRIATHLON CS INS SIZE 5 13MM
• 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: 6748011
• Report Number: 0002249697-2017-02313
• Device Sequence Number: 10817932
• Product Code: MBH
• UDI-Device Identifier: 07613327042320
• UDI-Public: 07613327042320
• 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
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/25/2021
• Device Catalogue Number: 5531P513
• Device Lot Number: LEX819
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/29/2017
• Supplement Date Received by Manufacturer: 08/18/2017
• Initial Report FDA Received Date: 07/27/2017
• Supplement Report FDA Received Date: 09/14/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 73 YR