MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 3. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5537-G-311
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.The following devices were also listed in this report: device name: triathlon asymmetric x3 patella; cat#:5551-g-320; lot#:5j5p.Device name: tri ts femur sz3 right; cat#: 5512-f-302; lot#: kwtt.Device name: tri cemented stem 12mmx50mm; cat#: 5560-s-112; lot#: 0044154l.Device name: tri ts baseplate size 3; cat#:5521-b-300; lot#: veyda.Device name: tri cemented stem 12mmx50mm; cat#: 5560-s-112; lot#: 0044804l.Device name: triathlon total knee system offset adapter 4mm; cat#: 5570-s-040; lot#: 0036345a.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.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
This pi is for the revision of the patient's right knee on (b)(6) 2020.In reporting a revision of the patient's right knee on (b)(6) 2020, the rep provided a revision implant sheet from (b)(6) 2020 for a poly swap which was performed due to infection.A 3x11 ts insert was exchanged for another 3x11 ts insert.

• Brand Name: NO 3. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 11MM
• 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: 10592845
• Report Number: 0002249697-2020-02001
• Device Sequence Number: 14407746
• Product Code: MBH
• UDI-Device Identifier: 07613327027136
• UDI-Public: 07613327027136
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2020

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: 01/31/2018
• Device Model Number: 5537-G-311
• Device Catalogue Number: 5537-G-311
• Device Lot Number: MMA71A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 09/28/2020
• 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
• Patient Weight: 71