MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #3 R-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5510-F-302
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/31/2021
Type of Reportable Event	Serious Injury
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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
After exposure, hip center through trialing were completed in dr¿s preferred order/method.There were no mako related issues throughout the procedure.After trialing, dr.Requested the following cemented components: femur: size 3 cr, tibia: size 2, poly: size 2x 10 mm, patella: size a35.I retrieved the implants and held them up for dr., the scrub tech and the circulator to see.I proceeded to read each implant box: ¿two by 10 poly.Three right cr cemented femur, two cemented baseplate and an a35 cemented patella.¿ dr.Then said, ¿yes.¿ i showed the circulator the boxes and read the expiration dates.The implants were opened and given to the sterile field.Dr.Cemented each component.After the submission of the charge sheet to jr rep, the wrong femur side was identified.Once jr rep identified the wrong femur side was implanted- he made contact with the surgeon.¿ spoke to mps.Implants were obtained from a cart with multiple common options for knee implants.Mps confirmed that after trialing, the surgeon removed the arrays and did not evaluate the knee after final implants were implanted.Spoke to jr rep.Once surgeon was notified, patient was returned to the operating room.Later the same day and the right-sided implant was revised to a left-sided implant.Rep provided the usage sheet from the primary procedure.
Additional Manufacturer Narrative
An event regarding incorrect selection involving a triathlon femoral component was reported.The event was confirmed via review of the provided implant sheet.Method & results: -device evaluation and results: not performed as the device 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: no other similar events were reported for the lot.Conclusion: it was reported that a right femoral component was implanted on the left knee instead of a left femoral component.The provided implant sheet was reviewed and confirmed that the reported device was implanted in the patient.It was also reported that the incorrect implant was shown and read aloud to the surgeon, scrub tech, and circulator prior to being placed in the sterile field.This information confirms the root cause of incorrect implant use was 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
After exposure, hip center through trialing were completed in dr¿s preferred order/method.There were no mako related issues throughout the procedure.After trialing, dr.Requested the following cemented components: femur: size 3 cr, tibia: size 2, poly: size 2x 10 mm, patella: size a35.I retrieved the implants and held them up for dr., the scrub tech and the circulator to see.I proceeded to read each implant box: ¿two by 10 poly.Three right cr cemented femur, two cemented baseplate and an a35 cemented patella.¿ dr.Then said, ¿yes.¿ i showed the circulator the boxes and read the expiration dates.The implants were opened and given to the sterile field.Dr.Cemented each component.After the submission of the charge sheet to jr rep, the wrong femur side was identified.Once jr rep identified the wrong femur side was implanted- he made contact with the surgeon.¿ spoke to mps.Implants were obtained from a cart with multiple common options for knee implants.Mps confirmed that after trialing, the surgeon removed the arrays and did not evaluate the knee after final implants were implanted.Spoke to jr rep.Once surgeon was notified, patient was returned to the operating room.Later the same day and the right-sided implant was revised to a left-sided implant.Rep provided the usage sheet from the primary procedure.

• Brand Name: TRIATHLON CR FEM COMP #3 R-CEM
• 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-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: joann lavatelli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12530265
• Report Number: 0002249697-2021-01619
• Device Sequence Number: 5159582
• Product Code: MBH
• UDI-Device Identifier: 07613327040265
• UDI-Public: 07613327040265
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2021

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: 04/30/2026
• Device Model Number: 5510-F-302
• Device Catalogue Number: 5510F302
• Device Lot Number: NB94Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female