MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #5 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-509
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Blister (4537)
Date of Event	11/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.The following devices were also listed in this report: 5536b500 tritanium bplate triathlon s5 ctd36435, 5517f502 triathlon p/a cr beaded #5r h229n, 5552-l-350 tritanium patella-asymmetric jn04.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.
Event or Problem Description
Patient reported that she had a right tka done on (b)(6) 2019 and experienced severe electrical burn due to the robotic arm used.Patient stated the 2 days after the surgery she started to get big blisters on her leg.A week after the surgery she was in the emergency room due to the blisters.Patient was sent to the wound care clinic for approx a month.Patient started to experience pain in (b)(6) 2020.The patient went to see her surgeon 3 weeks ago and was told to get an mri.Patient is mainly looking for the catalog, serial and lot of the robotic arm.
Additional Manufacturer Narrative
Reported event: an event regarding pain 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: a review of the provided medical information by a clinical consultant indicated: adverse event identified: severe blistering and skin break down lateral and inferior to the knee incision.Hazards: none clearly related to implant or the mako device.Conclusion of assessment: the patient had severe blistering and ultimately a grade 3 type of skin injury.It was felt by the clinical teams that this was from swelling much like fracture blistering.There was no actual support for that claim.The sources of cause of the blistering was unclear.The skin injury healed over a 1 month period with help from the wound care team.There was no evidence that the robot had any relation to the skin issues.The patient was apparently linking claims against the davinci device to the mako.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 experience pain.The exact cause of the event could not be determined because insufficient information was provided.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
Patient reported that she had a right tka done on (b)(6) 2019 and experienced severe electrical burn due to the robotic arm used.Patient stated the 2 days after the surgery she started to get big blisters on her leg.A week after the surgery she was in the emergency room due to the blisters.Patient was sent to the wound care clinic for approx a month.Patient started to experience pain in (b)(6) 2020.The patient went to see her surgeon 3 weeks ago and was told to get an mri.Patient is mainly looking for the catalog, serial and lot of the robotic arm.

• Brand Name: X3 TRIATHLON CS INSERT #5 9MM
• 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: 12150059
• Report Number: 0002249697-2021-01173
• Device Sequence Number: 19824958
• Product Code: MBH
• UDI-Device Identifier: 07613327045871
• UDI-Public: 07613327045871
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021

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: 07/31/2024
• Device Model Number: 5531-G-509
• Device Catalogue Number: 5531G509
• Device Lot Number: LJH790
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 07/12/2021
• Supplement Report FDA Received Date: 08/05/2021
• 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: Other
• Patient Age: 60 YR
• Patient Weight: 82