MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #5R; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-616-E
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	01/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Peri-prosthetic fracture, insert swap.Patient fell and came in through er.
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.Device not returned.
Additional Manufacturer Narrative
Device information updated based on medical review.Changed from 5531-g-616-e x3 triathlon cs insert #6 16mm to 5517f502 triathlon p/a cr beaded #5r.Reported event: an event regarding periprosthetic fracture involving a triathlon femoral component was reported.The event was confirmed via clinician review.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated: the post op x-rays with staples in place show a pressfit tka in anatomic position without evidence of mechanical complication.The second set of ap and lateral x-rays show a comminuted oblique distal femoral fracture around a tka.The implant log from 1/12/2022 reveals the fracture was reconstructed with a femoral nail.Per-prosthetic fracture above a pressfit tka is confirmed.It was reported that this fracture was caused by a fall.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's knee was revised due to peri-prosthetic fracture (distal femoral fracture) whereby the the fracture was reconstructed with a femoral nail and the insert was revised.Clinician review of provided records indicated that per-prosthetic fracture above a pressfit tka is confirmed.It was reported that this fracture was caused by a fall.No further investigation for this event is required.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Peri-prosthetic fracture, insert swap.Patient fell and came in through emergency room.*update on 6-apr-2022 per clinician review: "[.] the second set of ap and lateral x-rays show a comminuted oblique distal femoral fracture around a tka.The implant log from 1/12/2022 reveals the fracture was reconstructed with a femoral nail.[.]".

• Brand Name: TRIATHLON P/A CR BEADED #5R
• 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-LIMERICK; raheen business park; limerick NJ NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 13450980
• Report Number: 0002249697-2022-00177
• Device Sequence Number: 6198893
• Product Code: MBH
• UDI-Device Identifier: 07613327040968
• UDI-Public: 07613327040968
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2022

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: 12/31/2025
• Device Model Number: 5531-G-616-E
• Device Catalogue Number: 5517F502
• Device Lot Number: LRX9S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2022
• Supplement Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2020
• 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: 64 YR
• Patient Sex: Female
• Patient Weight: 95 KG