MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 7. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5537-G-716
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	10/11/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: triathlon®, total stabilizer femoral component, #7; cat# 5512-f-701; lot# iwoi; triathlon® total knee, universal tibial baseplate, 7; cat# 5521-b-700; lot# vobga; triathlon® x3®, symmetric patella, s36mm; cat# 5550-g-360; lot# 37xj; triathlon® total knee, cemented stem, 15mm; cat# 5560-s-115; lot# 0033942h; triathlon® total knee, cemented stem, 15mm; cat# 5560-s-215; lot# 0038629e.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 indicates the devices were manufactured and accepted into final stock with no reported discrepancies.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.Device not available.
Event or Problem Description
Patient underwent 2 stage exchange following primary tka in 2013.Patient had septic sepsis and underwent a 2 stage exchange over the course of 4 months in (b)(6) 2016 due to other health issue.Reported in q4_2016.Now 6 months later is revised again for prosthetic joint infection with only poly exchange.

• Brand Name: NO 7. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM
• 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: 6858778
• Report Number: 0002249697-2017-02738
• Device Sequence Number: 19057257
• Product Code: MBH
• UDI-Device Identifier: 07613327027495
• UDI-Public: 07613327027495
• 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: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/12/2017

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: 06/14/2021
• Device Catalogue Number: 5537-G-716
• Device Lot Number: RW31R8
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 09/12/2017
• 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: 63 YR
• Patient Weight: 95