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

Catalog Number	5532-G-411-E
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	02/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported a popping in his left knee.
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.
Event or Problem Description
Patient reported, a popping in his left knee.Pain was also reported.
Additional Manufacturer Narrative
The following devices were also listed in this report: tri ts baseplate size 4, cat#: 5521-b-400, lot#: ly47sb; triathlon ps fem component cemented, cat#: 5515-f-501, lot#: ldr3td; triathlon fix.Peg 2 per pk, cat#: 5575x000, lot#: eur9u.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding pain and audible noise involving a triathlon insert was reported.Audible noise from the knee was confirmed, via a provided video.Pain was also confirmed, but the origin of which could not be determined.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed, as the device remains implanted.Clinician review: a review of the provided medical records, by a clinical consultant indicated: "documentation provided describes a primary total knee replacement that was uncomplicated.X-rays show, a preoperative knee with tricompartmental osteoarthritis.Post operative x-rays show, a press fit tka in anatomic position.Interfaces are pristine.The patella tracks centrally.No postoperative clinical documentation was provided.Post operative tka popping nor its root cause cannot be determined, from the limited documentation provided".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 is experiencing pain and "popping" post-implantation.A video of the patient moving their knee was provided and an audible "popping" noise can be heard in the audio.A review of the provided medical records, by a clinical consultant indicated: "documentation provided, describes a primary total knee replacement that was uncomplicated.X-rays show, a preoperative knee with tricompartmental osteoarthritis.Post operative x-rays show, a press fit tka in anatomic position.Interfaces are pristine.The patella tracks centrally.No postoperative clinical documentation was provided.Post operative tka popping, nor its root cause cannot be determined, from the limited documentation provided".The origin of neither the pain nor the "popping" sound could be determined, from the information provided.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON PS 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 18844603
• Report Number: 0002249697-2024-00349
• Device Sequence Number: 7832781
• Product Code: MBH
• UDI-Device Identifier: 07613327338607
• UDI-Public: 07613327338607
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2024

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 Catalogue Number: 5532-G-411-E
• Device Lot Number: RE3N95
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2024
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2023
• 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: Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 100 KG