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-311
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 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.
Event or Problem Description
Knee revision due to instability.
Event or Problem Description
Knee revision due to instability.
Additional Manufacturer Narrative
Reported event: an event regarding instability involving a triathlon insert was reported.The event was confirmed through clinician review of the provided medical records.Method & results: -device evaluation and results: not performed as no product was returned.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: re pi which is from sweden and represents a female patient, dob (b)(6) 1954 described as 162 cm tall and weighing 84 kg.Her date of implantation is listed as (b)(6) 2011 and explantation (b)(6) 2021.The event description states: "knee revision due to instability." (b)(6) 2011 brief translated operative note right tka: ".Triathlon.Cement free.No perio complications.Stable knee, full mobility, norm alignment." (b)(6) 2021 brief translated operative note: ".Revision plastic wear.Change to plastic after synovectomy.Planned home today." undated x-rays: 3 sets of ap, lat.And patellar views: right uncemented tha with no patellar resurfacing, reduced, nominal, no gross pathology.Undated x-rays: 2 ap, 1 lat., 1 pat.View: same tka with medial compartment narrowing and anterior subluxation of tibial component.No clinical or pmh, no complete operative reports, no dated serial x-rays, no examination of explanted components.Based upon several x-rays, the event description appears to be confirmed, but insufficient information is available to create a medical report for this case.-device history review: all 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 reported lot.Conclusion: the event was confirmed through clinician review of the provided medical records which indicated: based upon several x-rays, the event description appears to be confirmed, but insufficient information is available to create a medical report for this case.Further information such as clinical or patient medical history, operative reports, dated serial x-rays, and examination of explanted components are required to complete the investigation and determine a root cause.No further investigation is required at this time.If additional information becomes 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
• MDR Report Key: 11691406
• Report Number: 0002249697-2021-00701
• Device Sequence Number: 19613464
• Product Code: MBH
• UDI-Device Identifier: 07613327050448
• UDI-Public: 07613327050448
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2021

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: 08/31/2016
• Device Model Number: 5530-G-311
• Device Catalogue Number: 5530-G-311
• Device Lot Number: MKM34P
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 84