MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5530-G-409-E
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544)
Date of Event	07/13/2021
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.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.The following devices were also listed in this report: triathlon cr fem comp #4 r-cem; cat # 5510f402; lot # lsd2y.Triathlon prim tib baseplate - cemented; cat # 5520-b-400; lot # gxl9ea.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
A relative of an acquaintance of a stryker employee from (b)(6) recently had a tka on (b)(6) 2021.Attached in attachment-intake is a photo of the implants used.The surgery was mako assisted.Since the surgery she has had abnormal results, inconsistent with a typical surgery.She has less than 60 degrees of flexion and that is only with mechanical assist.For privacy reasons, i keep the initial reporter information to a minimum.
Event or Problem Description
A relative of an acquaintance of a stryker employee from uk recently had a tka on (b)(6) 2021.Attached in attachment-intake is a photo of the implants used.The surgery was mako assisted.Since the surgery she has had abnormal results, inconsistent with a typical surgery.She has less than 60 degrees of flexion and that is only with mechanical assist.For privacy reasons, i keep the initial reporter information to a minimum.
Additional Manufacturer Narrative
Added implant date.Reported event: an event regarding rom involving a triathlon insert was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted.-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.Conclusions: it was reported that the patient has less than 60 degrees of flexion and that is only with mechanical assist.The exact cause of the event could not be determined because insufficient information was provided.Further information such as 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 additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• 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 NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12317956
• Report Number: 0002249697-2021-01383
• Device Sequence Number: 4454847
• Product Code: MBH
• UDI-Device Identifier: 07613327382860
• UDI-Public: 07613327382860
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2021

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: 03/31/2026
• Device Model Number: 5530-G-409-E
• Device Catalogue Number: 5530-G-409-E
• Device Lot Number: 4W8DYE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2021
• 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 Sex: Female