MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #7 L-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5510F701
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.H3 other text : not returned.
Event or Problem Description
Cemented prosthesis 5510f701 was opened during a cementless procedure in error.Both surgeon and scrub nurse checked box.Prosthesis was implanted without cement.Become aware of event through joint registry highlighting to the hospital that no cement was used.Left tka procedure.Revision of component.
Additional Manufacturer Narrative
An event regarding incorrect selection involving a triathlon femoral component was reported.The event was 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 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 a cemented femoral component was implanted in the patient's knee instead of a press-fit (cementless) femoral component.The patient was revised the following day to correct the error.The provided implant sheet was reviewed and confirmed that the reported device, a size 7 triathlon cruciate retaining femoral component, left side, catalog: 5510-f-701, lot: tdp4d was implanted in the patient.The "no" box next to "femoral cement" is marked with a check mark.It should be noted that the stryker label on the carton includes brand name, product name, and associated product descriptions like "cemented." the application type by part number is further noted in the triathlon knee system surgical protocol.The reported event is considered to be the result of user error as no manufacturing-related product problem was found given 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.
Event or Problem Description
Cemented prosthesis 5510f701 was opened during a cementless procedure in error.Both surgeon and scrub nurse checked box.Prosthesis was implanted without cement.Become aware of event through joint registry highlighting to the hospital that no cement was used.Left tka procedure.Revision of component.Update: the revision surgery was successfully completed on the 18/05, with a new cemented component.No further information to present, at this stage.

• Brand Name: TRIATHLON CR FEM COMP #7 L-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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19330538
• Report Number: 0002249697-2024-00745
• Device Sequence Number: 6910932
• Product Code: MBH
• UDI-Device Identifier: 07613327040333
• UDI-Public: 07613327040333
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K040267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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: 5510F701
• Device Lot Number: TDP4D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2023
• 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: Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 83 KG