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 Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
It was reported that during a primary left mako knee, a right-sided femoral component was implanted.The rep read off and handed the nurse the implant, who opened it at the back table.The nurse opened and read off the implant to the scrub tech, who then opened the implant to the field (it is unknown if the scrub tech read it off).Discovery was made post-operatively.Current surgical plan is to observe and assess, with the patient's agreement as the patient is pain free.Rep provided the usage sheet and confirmed that no further information will be released by the hospital or surgeon.
Event or Problem Description
It was reported that during a primary left mako knee, a right-sided femoral component was implanted.The rep read off and handed the nurse the implant, who opened it at the back table.The nurse opened and read off the implant to the scrub tech, who then opened the implant to the field (it is unknown if the scrub tech read it off).Discovery was made post-operatively.Current surgical plan is to observe and assess, with the patient's agreement as the patient is pain free.Rep provided the usage sheet and confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event:  an event regarding incorrect selection involving a triathlon component was reported.  conclusion:  it was reported that during a primary left mako knee, a right-sided femoral component was implanted.Based on the provided information it has been determined that this event is associated with an off-label application.A review of provided implant sheet indicates that the device was clearly labeled for side "rt" (right).No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 12597856
• Report Number: 0002249697-2021-01681
• Device Sequence Number: 11631123
• Product Code: MBH
• UDI-Device Identifier: 07613327040265
• UDI-Public: 07613327040265
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2021

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: 04/13/2026
• Device Model Number: 5510-F-302
• Device Catalogue Number: 5510F302
• Device Lot Number: NBP9S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 10/08/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Age: 46 YR
• Patient Sex: Female