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

Catalog Number	5532-G-719
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	03/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: triathlon ps fem comp #7r-cem; cat#5515f702; lot#bjd7r, tri ts baseplate size 7; cat#5521-b-700; lot#wrz3a, triathlon symmetric x3 patella; cat#5550-g-391; lot#x2aj, tri cemented stem 12mmx50mm; cat#5560-s-112; lot#0042734e, triathlon fix.Peg 2 per pk; cat#5575x000; lot#bs99n, tri post augment sz7 5mm; cat#5543-a-700; lot#us3z.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Patient underwent index surgery outside of cors scope.On (b)(6) 2017 the patient underwent a revision (re-implantation) for pji.Patient got re-infected and now all components were removed.
Additional Manufacturer Narrative
An event regarding infection involving a triathlon insert component was reported.The event was not confirmed.Device evaluation and results: not performed as no product was returned for evaluation.No medical records were received for review with a clinical consultant.Indicated all devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot or sterile lot referenced.The exact cause of the event could not be determined because insufficient information was provided.Further information such as product evaluation, pre- and post-operative x-rays, pathology, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Patient underwent index surgery outside of cors scope.On (b)(6) 2017 the patient underwent a revision (re-implantation) for pji.Patient got re-infected and now all components were removed.

• 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: 7154349
• Report Number: 0002249697-2017-03767
• Device Sequence Number: 19288461
• Product Code: MBH
• UDI-Device Identifier: 07613327046304
• UDI-Public: 07613327046304
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2018

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: 11/04/2021
• Device Catalogue Number: 5532-G-719
• Device Lot Number: J24WK3
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 02/21/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 100