MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI PRESS-FIT STEM 17MM X 100MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5565-S-017
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Limb Fracture (4518)
Date of Event	07/09/2021
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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
Event or Problem Description
Patient had bilateral index tka (outside of cors scope (b)(6) 2011).Had a pji of both knees.Undergoes bilateral tka revision on (b)(6) 2020 with all components exchanged, and antibiotic cement loaded for treatment (stage 1 of a 2-stage revision).Patient returns for a left pji knee revision on (b)(6) 2021.All components exchanged (stage 2 of a 2-stage revision.Now the patient suffers a femoral periprosthetic fracture (b2) and undergoes revision of femoral, and rotating components on (b)(6) 2021.
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture involving a triathlon stem was reported.The event was confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical information by a clinical consultant indicated: "conclusion of assessment: this inquiry reports a patient who had bilateral total knee replacements in 2011and approximately 9 years later developed periprosthetic infection of both knees.A debridement of was carried out of both knees with insertion of antibiotic impregnated spacers.The left knee was reimplanted about 2 ½ months later and the right was reimplanted about 2 ½ months after that.The patient sustained a periprosthetic fracture 6 months later and underwent distal femoral replacement with a rotating hinge.I can confirm that these events took place since i was able to review the xrays and operation reports.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of periprosthetic joint infection is multifactorial, but most likely after 9 years the infections came from hematogenous seeding from a remote location.Causes of periprosthetic fracture likewise is multifactorial including surgical technique factors, patient activity and weight factors, and trauma." product history review: review of the device history records indicate the 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.Conclusions: it was reported that the patient was revised due to femoral periprosthetic fracture.The event was confirmed by a review of the provided medical records by a clinical consultant which stated the following: "this inquiry reports a patient who had bilateral total knee replacements in 2011 and approximately 9 years later developed periprosthetic infection of both knees.A debridement of was carried out of both knees with insertion of antibiotic impregnated spacers.The left knee was reimplanted about 2 ½ months later and the right was reimplanted about 2 ½ months after that.The patient sustained a periprosthetic fracture 6 months later and underwent distal femoral replacement with a rotating hinge.I can confirm that these events took place since i was able to review the xrays and operation reports.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of periprosthetic joint infection is multifactorial, but most likely after 9 years the infections came from hematogenous seeding from a remote location.Causes of periprosthetic fracture likewise is multifactorial including surgical technique factors, patient activity and weight factors, and trauma." the medical records indicated that the patient fell prior to the revision; this trauma likely contributed to the event.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Patient had bilateral index tka (outside of cors scope (b)(6) 2011).Had a pji of both knees.Undergoes bilateral tka revision on (b)(6) 2020 with all components exchanged, and antibiotic cement loaded for treatment (stage 1 of a 2-stage revision).Patient returns for a left pji knee revision on (b)(6) 2021.All components exchanged (stage 2 of a 2-stage revision.Now the patient suffers a femoral periprosthetic fracture (b2) and undergoes revision of femoral, and rotating components on (b)(6) 2021.

• Brand Name: TRI PRESS-FIT STEM 17MM X 100MM
• 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, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 13729004
• Report Number: 0002249697-2022-00372
• Device Sequence Number: 17320947
• Product Code: MBH
• UDI-Device Identifier: 07613327026788
• UDI-Public: 07613327026788
• 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): 06/21/2022

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: 11/30/2024
• Device Model Number: 5565-S-017
• Device Catalogue Number: 5565-S-017
• Device Lot Number: 0101385D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White