MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 3. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5537-G-316-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: patient had a 2 stage revision due to infection.Patient is inquiring if the stryker implants used in the 2nd stage revision are subject to a recall.Patient did not report any issues after revision surgery.
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.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: triathlon femoral distal augment 5mm - size 3 right; cat# 5540-a-302 ; lot# egr9v, triathlon femoral distal augment 5mm - size 3 right; cat# 5540-a-302; lot# b9a4t, triathlon total knee system offset adapter 2mm;cat# 5570-s-020; lot# 0075380j, tri press-fit stem 16mm x 100mm; cat# 5565-s-016; lot# 0083070h, tri ts baseplate size 3; cat# 5521-b-300; lot# ea44xa, triathlon total knee system offset adapter 2mm; cat# 5570-s-020; lot# 0088921h, tri press-fit stem 16mm x 100mm; cat# 5565-s-016; lot# 0083067m, tri ts femur sz3 right; cat# 5512-f-302; lot# b3a3b, simplex p with tobramycin 1 pack; cat# 6197-9-001; lot# mla083.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: NO 3. 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 15154547
• Report Number: 0002249697-2022-01137
• Device Sequence Number: 5197078
• Product Code: MBH
• UDI-Device Identifier: 07613327288179
• UDI-Public: 07613327288179
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/03/2022

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: 05/31/2024
• Device Model Number: 5537-G-316-E
• Device Catalogue Number: 5537-G-316-E
• Device Lot Number: 6H263D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 61 KG