MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMP #1L-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5515-F-101
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Limb Fracture (4518)
Date of Event	08/26/2021
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 has been reported "fractures of both femoral condyle occurred since ps box is huge.".
Event or Problem Description
It has been reported "fractures of both femoral condyle occurred since ps box is huge.".
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture 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: a review of the provided medical information by a clinical consultant indicated: i cannot completely confirm that this event took place since there are no intraoperative photos and no pre-op and immediate post-op x-rays of the primary procedure or the operation report of the revision procedure.Regarding the possible root cause of this event, i cannot determine it with certainty.This type of fractures is multifactorial in nature.[¿] in my opinion these are iatrogenic in nature relating to the way the box is cut, the preparation of the side walls and back wall of the box and the technique of insertion of the femoral component.-product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that fractures of both femoral condyle occurred since ps box is huge.Clinician review of the provided x-ray could not confirm this event.The exact cause of the event could not be determined because insufficient information was provided.Further information such as intraoperative photos, pre-op and immediate post-op x-rays of the primary procedure or the operation report of the revision procedure are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON PS FEM COMP #1L-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: 12502759
• Report Number: 0002249697-2021-01588
• Device Sequence Number: 14430394
• Product Code: MBH
• UDI-Device Identifier: 07613327040685
• UDI-Public: 07613327040685
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/04/2022

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 Model Number: 5515-F-101
• Device Catalogue Number: 5515F101
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 01/05/2022
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown
• Patient Weight: 50 KG