MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5537-G-616
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	10/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "the spine on the size 6x16mm ts insert sheared off and became wedged in femoral notch.No medical or operative records available.The primary knee was done in another hospital in 2007." spoke to rep: no trauma was reported to the rep.Confirmed that no further information will be released are the hospital or surgeon.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
As reported: "the spine on the size 6x16mm ts insert sheared off and became wedged in femoral notch.No medical or operative records available.The primary knee was done in another hospital in 2007." spoke to rep: no trauma was reported to the rep.Confirmed that no further information will be released are the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a triathlon insert was reported.The event was confirmed via medical review method & results: device evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The photograph shows a recently explanted triathlon insert with a crack/fracture, biological matter as well as damage consistent with attempted implantation/explantation.Material analysis: not performed as the device was not returned.Dimensional inspection: not performed as the device was not returned.Functional inspection: not performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: material reviewed: 10/27/2021: stryker report undated unlabeled: ap right knee x-ray.Cemented primary tka triathlon with planning tool.No gross abnormalities undated unlabeled: lateral knee x-ray.Cemented primary tka triathlon with box.No gross abnormalities other than perhaps a small lucency at box.Undated unlabeled: intraoperative photo.Knee open with exposed tka.Tibial polyethylene post fractured and lodged in the femoral notch.Confirmation: the event was confirmed.Based on the intraoperative phot the polyethylene post was broken.Root cause: the root cause cannot be determined without additional medical records.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: no other similar events were reported for the lot.Conclusion: the event was confirmed via medical review.The exact cause of the event could not be determined because insufficient information was provided.Additional information including return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
As reported: "the spine on the size 6x16mm ts insert sheared off and became wedged in femoral notch.The primary knee was done in another hospital in 2007." spoke to rep: no trauma was reported to the rep.

• Brand Name: NO 6. 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12829482
• Report Number: 0002249697-2021-01921
• Device Sequence Number: 1492218
• Product Code: MBH
• UDI-Device Identifier: 07613327027419
• UDI-Public: 07613327027419
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K070095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• 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): 02/21/2022

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 Model Number: 5537-G-616
• Device Catalogue Number: 5537-G-616
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 72 YR
• Patient Sex: Male