MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5537-G-613
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	08/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate 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.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: sterile fluted headless 1/8" pin 3.5" long; cat#7650-2038a; lot#rdee092.Tri post augment sz7 10mm; cat#5544-a-700; lot#be99l.Triathlon stem extender 25mm; cat#5571-s-025; lot#6p2e9l.Tri press-fit stem 21mm x 100mm; cat#5565-s-021; lot#0077028d.Triathlon stem extender 25mm; cat#5571-s-025; lot#1e5dmd.Tri ts femur sz7 right; cat#5512-f-702; lot#ubui.Tri ts baseplate size 6; cat#5521-b-600; lot#dli7ta.Triathlon symmetric x3 patella; cat#5550-g-339; lot#j8nd.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not available.
Event or Problem Description
Dr.Revised a triathlon ts insert performing an i&d due to signs of infection.He changed from a sz 6x13 to a 6x16.This patient already was revised from an arthrex total knee to a spacer due to infection.The triathlon ts was implanted on (b)(6) 2019.Update 06/august/2019: spoke to rep.Original implant surgery (b)(6) 2019 took place in the same hospital as revision.Rep provided usage sheets from primary stryker implant and revision, and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 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: 8955414
• Report Number: 0002249697-2019-03045
• Device Sequence Number: 2444518
• Product Code: MBH
• UDI-Device Identifier: 07613327027402
• UDI-Public: 07613327027402
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/03/2019

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: 10/31/2019
• Device Catalogue Number: 5537-G-613
• Device Lot Number: MNNAN7
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 09/03/2019
• 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: 52 YR