MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5532-G-309
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	05/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: tri ts femur sz3 right; cat# 5512-f-302; lot# v1gd diathlon prim tib baseplate - cemented; cat# 5520-b-300; lot# vsd4a triathlon asymmetric x3 patella; cat# 5551-g-320; lot# 2vnv it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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.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 reported for the manufacturing lot.Not available.
Event or Problem Description
Patient had a right total knee replacement (b)(6) 2016.She showed up for follow up 10 months post op with pain and radiographic changes.She was worked up for infection.She was scheduled for explantation and implantation of an antibiotic spacer.
Additional Manufacturer Narrative
Implant date has been changed to (b)(6) 2016.An event regarding infection involving a triathlon insert was reported.The event was not confirmed.Product evaluation and results: could not be performed as no items associated with the event were returned or made available for identification or evaluation.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.Product history review: all products in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there has been no other similar event for the reported lot and sterile lot.Conclusions: the reported event could not be confirmed as clinical history, follow-up notes and results of bloodwork for infection were not provided.A capa trend analysis was conducted for the reported failure mode and concluded infection may result from other factors not necessarily related to the device.No further investigation for this event is possible at this time.Further information such as return of product, pre- and post-op xrays, office notes, operative reports, patient history, histopathology report & follow-up notes are needed to investigate this event further.If additional information and/or product becomes available, this investigation will be reopened.Product surveillance will continue to monitor for trends.
Event or Problem Description
Patient had a right total knee replacement (b)(6) 2016.She showed up for follow up 10 months post op with pain and radiographic changes.She was worked up for infection.She was scheduled for explantation and implantation of an antibiotic spacer.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• 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: 6637416
• Report Number: 0002249697-2017-01850
• Device Sequence Number: 507528
• Product Code: MBH
• UDI-Device Identifier: 07613327050646
• UDI-Public: (01)07613327050646(11)160519(17)210519(10)4L3W9K
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 09/18/2017

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: 05/19/2021
• Device Model Number: 5532-G-309
• Device Catalogue Number: 5532-G-309
• Device Lot Number: 4L3W9K
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/16/2017
• Supplement Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 06/13/2017
• Supplement Report FDA Received Date: 09/18/2017
• 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: 59 YR
• Patient Weight: 84