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-309-E
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	01/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This pi is for the manipulation under anesthesia (mua) on (b)(6) 2021.Records provided by the rep for revision of patient's left knee on (b)(6) 2021 include an operative report for an mua performed on (b)(6) 2021 due to persistent scarring and 'trouble regaining her motion.' rep provided a 'patient packet' and confirmed that no further information will be released by the hospital or surgeon.
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 #3 l-cem; cat # 5510f301; lot # jyj2e simplex p full dose 1 pack; cat # 6191-1-001; lot # rgb042 triathlon prim tib baseplate - cemented; cat # 5520-b-300; lot # ebz4ob triathlon asymmetric x3 patella; cat # 5551-g-320-e; lot # 809y it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Additional Manufacturer Narrative
An event regarding rom involving a triathlon insert was reported.The event was confirmed via clinician review of the provided medical records.Method & results: device evaluation and results: material analysis, visual, dimensional and functional inspections were not performed as the device remains implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated: conclusion/assessment: a patient underwent a tka and an mua.Instability of the knee was diagnosed as well as advance hip arthritis at approximately 1 year follow-up.A revision tka was recommended.The procedure was apparently performed but this was only documented in the pi report.Event confirmation: a primary tka, mua and an exam with instability could be confirmed.A revision tka could not be confirmed root cause: the root cause of the proposed revision was knee instability.But the event was not confirmed.Device 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.Conclusion: a review of the provided medical records by a clinical consultant indicated: conclusion/assessment: a patient underwent a tka and an mua.Instability of the knee was diagnosed as well as advance hip arthritis at approximately 1 year follow-up.A revision tka was recommended.The procedure was apparently performed but this was only documented in the pi report.Event confirmation: a primary tka, mua and an exam with instability could be confirmed.A revision tka could not be confirmed root cause: the root cause of the proposed revision was knee instability.But the event was not confirmed.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.
Event or Problem Description
This pi is for the manipulation under anesthesia (mua) on (b)(6) 2021.Records provided by the rep for revision of patient's left knee on (b)(6) 2021 include an operative report for an mua performed on (b)(6) 2021 due to persistent scarring and 'trouble regaining her motion.' rep provided a 'patient packet' and confirmed that no further information will be released by the hospital or surgeon.

• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16402994
• Report Number: 0002249697-2023-00168
• Device Sequence Number: 14293974
• Product Code: MBH
• UDI-Device Identifier: 07613327382716
• UDI-Public: 07613327382716
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2023

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: 08/31/2025
• Device Model Number: 5530-G-309-E
• Device Catalogue Number: 5530-G-309-E
• Device Lot Number: TJ28JM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2023
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2020
• 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: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 68 KG