MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #5 R-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5510-F-502
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/20/2021
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.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
Primary right mako knee.Post-operatively, it was discovered that a cemented femoral component was put into a knee planned for a press-fit femoral component.Surgeon was notified and 1 day post-op, the component was removed and a cemented femoral component was cemented in.Rep confirmed there are no allegations against the package labeling or the package contents of the original implant.Rep also confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Added d6a & d6b (implant & explant dates) reported event an event regarding incorrect selection involving a triathlon femoral component 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 was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate the 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 post-operatively, it was discovered that a cemented femoral component was put into a knee planned for a press-fit femoral component.Surgeon was notified and 1 day post-op, the component was removed and a cemented femoral component was cemented in.Sale representative confirmed there are no allegations against the package labeling or the package contents of the original implant.The event is likely caused due to user error.However, the exact cause of the event could not be determined.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Primary right mako knee.Post-operatively, it was discovered that a cemented femoral component was put into a knee planned for a press-fit femoral component.Surgeon was notified and 1 day post-op, the component was removed and a cemented femoral component was cemented in.Rep confirmed there are no allegations against the package labeling or the package contents of the original implant.Rep also confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: TRIATHLON CR FEM COMP #5 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 12814345
• Report Number: 0002249697-2021-01893
• Device Sequence Number: 4543082
• Product Code: MBH
• UDI-Device Identifier: 07613327040302
• UDI-Public: 07613327040302
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2022

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: 06/30/2026
• Device Model Number: 5510-F-502
• Device Catalogue Number: 5510F502
• Device Lot Number: L4H4S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2021
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2021
• 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: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male