MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #4L; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5517-F-401
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
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
As originally reported: "when doing a right total knee replacement.A left femoral knee implant was used instead of a right femoral implant." spoke to rep, who provided usage sheet.A stryker rep was present for the procedure.Discovery was made when reconciling hospital inventory.Patient is reported as asymptomatic.Treatment plan is to observe and assess the patient's progress, no plan for revision as of the time of report.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 user error involving a triathlon femoral component was reported.The event was confirmed by usage sheet method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted clinician review: no medical records were received for review with a clinical consultant.Product 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 lot referenced.Conclusions: the event was confirmed by usage sheet as it indicates r tka (right tka) and device is left.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pre- and post-operative x-rays and the primary operative report as well as follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
As originally reported: "when doing a right total knee replacement.A left femoral knee implant was used instead of a right femoral implant." spoke to rep, who provided usage sheet.A stryker rep was present for the procedure.Discovery was made when reconciling hospital inventory.Patient is reported as asymptomatic.Treatment plan is to observe and assess the patient's progress, no plan for revision as of the time of report.Rep provided the usage sheet and confirmed that no further information will be released by the hospital operating room surgeon.

• Brand Name: TRIATHLON P/A CR BEADED #4L
• 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: 12251798
• Report Number: 0002249697-2021-01294
• Device Sequence Number: 5001889
• Product Code: MBH
• UDI-Device Identifier: 07613327040937
• UDI-Public: 07613327040937
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2021

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: 12/31/2025
• Device Model Number: 5517-F-401
• Device Catalogue Number: 5517F401
• Device Lot Number: LHL4C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 08/30/2021
• 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: Hospitalization
• Patient Age: 53 YR