MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-513-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
This pi is for the revision on (b)(6) 2021.Patient had bilateral index tka (outside of cors scope).Patient is admitted with pain and bilateral knee pji.Undergoes bilateral revision on (b)(6) 2021 with all components exchanged, and antibiotic loaded cement for treatment.Patient returns for persistent right knee pji on (b)(6) 2021 for an i&d and poly exchanged reported as cors per (b)(4) knee.Patient returns with persistent pji, undergoes new revision with an i&d and a poly exchange only.Reported as cors per (b)(4).Patient returns (b)(6) 2021 with persistent pji, undergoes another revision with an i&d and a poly exchange only.
Additional Manufacturer Narrative
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.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.The following devices were also listed in this report: 5512-f-502; tri ts femur sz5 right; ggb9e.5521-b-500; tri ts baseplate size 5; ggs4ga 5550-g-339-e; triathlon symmetric x3 patella; ty1p.5549-a-672; triathlonctrfemconeaug sz 7&8r; l70m1.5549-a-150; triathlon sym cone aug sz e; hhp8.5560-s-212; tri cemented stem 12mmx100mm; 0090874j.5543-a-500; tri post augment sz5 5mm; ery7e.5540-a-502; triathlon femoral distal augment 5mm - size 5 right; dzo7e.5546-a-501; tri lm/rl tib aug sz5 10mm; erfca3d.5560-s-215; triathlon cemented stem-15mm x 100mm; 0077017a.5546-a-502; tri rm/ll tib aug sz5 10mm; erffm5d.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Additional Manufacturer Narrative
Corrected data: device details an event regarding infection involving a triathlon insert was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.There have been no other similar events for the sterile lot referenced.Conclusion: all stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance with applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.The following devices were also listed in this report: 5512-f-502; tri ts femur sz5 right; ggb9e 5521-b-500; tri ts baseplate size 5; ggs4ga 5550-g-339-e; triathlon symmetric x3 patella; ty1p 5549-a-672; triathlonctrfemconeaug sz 7&8r; l70m1 5549-a-150; triathlon sym cone aug sz e; hhp8 5560-s-212; tri cemented stem 12mmx100mm; 0090874j 5543-a-500; tri post augment sz5 5mm; ery7e 5540-a-502; triathlon femoral distal augment 5mm - size 5 right; dzo7e 5546-a-501; tri lm/rl tib aug sz5 10mm; erfca3d 5560-s-215; triathlon cemented stem-15mm x 100mm; 0077017a 5546-a-502; tri rm/ll tib aug sz5 10mm; erffm5d it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
This pi is for the revision on (b)(6) 2021.Patient had bilateral index tka (outside of cors scope).Patient is admitted with pain and bilateral knee pji.Undergoes bilateral revision on (b)(6), 2021 with all components exchanged, and antibiotic loaded cement for treatment.Patient returns for persistent right knee pji on (b)(6) 2021 for an i&d and poly exchanged reported as cors per 13236 knee.Patient returns with persistent pji, undergoes new revision with an i&d and a poly exchange only.Reported as cors per 13236(2).Patient returns february (b)(6) 2021 with persistent pji, undergoes another revision with an i&d and a poly exchange only.

• Brand Name: NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 9MM
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12808415
• Report Number: 0002249697-2021-01880
• Device Sequence Number: 4778120
• Product Code: MBH
• UDI-Device Identifier: 07613327336719
• UDI-Public: 07613327336719
• 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: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2022

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: 10/24/2023
• Device Model Number: 5531-G-513-E
• Device Catalogue Number: 5537-G-509
• Device Lot Number: 2J3JLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 11/14/2021
• Supplement Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2018
• 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: 49 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White