MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE1 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531G109
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	10/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: tri ts baseplate size 2; cat# 5521-b-200; lot# d914xb.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.It was noted that the device is not available for evaluation.If additional information is received, 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 reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
As reported: "size 1 poly implanted on size 2 universal baseplate.Planned size 1, cut to plan.Dr changed tibia to a 2 due to bone quality (rep confirmed additional cutting was not required).Implants were placed on a small prep table by rep, and nurse circulator held implants up for dr to read labels.Dr.Stopped operating, turned around and slowly read each and every item on label of each implant, and confirmed that is correct, nurse re-read size and expiration to scrub person, then opened implants." spoke to rep.Patient has developed a significant hematoma and revision surgery is planned to occur on or by (b)(6) 2019.Update: mps was in charge of running this mako tka case.On monday, (b)(6) 2019, jr rep noticed the discrepancy during restocking.The sales sheet was reviewed and it was confirmed that a size 1 femur, size 2 tibia and size 1 tibia polyethylene insert were implanted.Spoke to mps.There are no allegations against the robot or any of the cuts made in the primary procedure.Cause/ contributor for the hematoma not reported.
Additional Manufacturer Narrative
Additional information: explant date.An event regarding incorrect selection and patient factors (hematoma) involving a triathlon insert was reported.The incorrect device selection was confirmed as the primary implant sheet was received and the discrepancy in sizes was documented.Hematoma was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: no medical records were received for review with a clinical consultant.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 investigation concluded that the incorrect selection was caused by user error.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
As reported: "size 1 poly implanted on size 2 universal baseplate.Planned size 1, cut to plan.Dr changed tibia to a 2 due to bone quality (rep confirmed additional cutting was not required).Implants were placed on a small prep table by rep, and nurse circulator held implants up for dr to read labels.Dr.Stopped operating, turned around and slowly read each and every item on label of each implant, and confirmed that is correct, nurse re-read size and expiration to scrub person, then opened implants." spoke to rep.Patient has developed a significant hematoma and revision surgery is planned to occur on or by (b)(6) 2019.Update: mps was in charge of running this mako tka case.On (b)(6) 2019, jr rep noticed the discrepancy during restocking.The sales sheet was reviewed and it was confirmed that a size 1 femur, size 2 tibia and size 1 tibia polyethylene insert were implanted.Spoke to mps.There are no allegations against the robot or any of the cuts made in the primary procedure.Cause/ contributor for the hematoma not reported.Update 27/november/2019 wg: on (b)(6) 2019, rep was able to confirm that the patient was revised on (b)(6) 2019, rep was not present for the procedure.Rep also confirmed via phone that no further information will be available.

• Brand Name: X3 TRIATHLON CS INS SIZE1 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: 9364499
• Report Number: 0002249697-2019-03851
• Device Sequence Number: 14104900
• Product Code: MBH
• UDI-Device Identifier: 07613327045581
• UDI-Public: 07613327045581
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2020

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: 04/30/2022
• Device Catalogue Number: 5531G109
• Device Lot Number: LFT416
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 01/07/2020
• 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: 73 YR
• Patient Weight: 80