MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5537-G-509
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/05/2021
Type of Reportable Event	Serious Injury
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.
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.
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 13236knee.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 (b)(6) 2021 with persistent pji, undergoes another revision with an i&d and a poly exchange only.
Additional Manufacturer Narrative
Corrected data: device information an event regarding infection involving a triathlon insert was reported.The event was not confirmed.Method & results: device evaluation and results: visual, dimensional, functional and material analysis could not be performed as the device not returned clinician review: no medical records were received for review with a clinical consultant.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot and sterile lot.Conclusions: all stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Additional information including pathology reports, operative reports, progress notes, x-rays are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.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.

• Brand Name: NO 5. 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
• 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: 12808414
• Report Number: 0002249697-2021-01881
• Device Sequence Number: 4778119
• Product Code: MBH
• UDI-Device Identifier: 07613327027303
• UDI-Public: 07613327027303
• 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: 2011
• 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): 01/17/2022

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: 01/31/2023
• Device Model Number: 5537-G-509
• Device Catalogue Number: 5537-G-513
• Device Lot Number: N43N9A
• 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: 01/04/2022
• Initial Report FDA Received Date: 11/14/2021
• Supplement Report FDA Received Date: 01/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2018
• 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