MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #5; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5520B500
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient visited office and x-rays revealed an asymmetric joint space and supposed tibial baseplate fracture with poly wear.Patient had revision surgery.
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 similar events for the lot referenced.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a triathlon baseplate was reported.The event was confirmed via evaluation of the returned device and clinician review of the provided medical records.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device was performed as part of the material analysis: "images show the proximal and distal surfaces of the tibial baseplate, with fracture location highlighted by arrow.Also included in the images is the tibial insert.On visual examination, fracture of the posterior-medial area of the baseplate was observed.Bone cement was observed on the distal surface of the baseplate.[.] figures show a stereo microscope image of the full fracture surface associated with the posterior side of the baseplate and show the full fracture surface associated with the anterior side, with the approximate fracture origin location." material analysis: a material analysis was performed on the returned device which concluded the following: "review of triathlon baseplate, catalogue # 5520-b-500, lot code ea9jm confirmed fracture of the baseplate.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture through the baseplate in fatigue.No manufacturing or material related defects were observed on the device surfaces examined." clinician review: a review of the provided medical information by a clinical consultant indicated: "no medical records were provided for review other than a series of x-rays.No medical history was provided for review.The pi report noted a revision surgery for marked polyethylene wear and a tibial implant fracture.No records of the revision were provided.The x-rays do show severe medial joint space loss and what appeared to be metallic fracture of the tibial baseplate.Event confirmation: asymmetric joint space and tibial implant fracture can be confirmed.Revision surgery cannot be confirmed.Root cause: the root cause of the severe loss of joint space is likely polyethylene wear or failure but this cannot be determined without examination of the implant or additional records.The root cause of the implant fracture cannot be determined.The root cause of the unconfirmed revision would be the combination of the prior two conditions noted." 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 the patient was revised due to fracture of the tibial baseplate and wear of the insert.A material analysis was performed on the returned devices which concluded the following: "characterisation using stereo microscopy and scanning electron microscopy confirmed fracture through the baseplate in fatigue.No manufacturing or material related defects were observed on the device surfaces examined." a review of the provided medical records by a clinical consultant further confirmed the event but was unable to identify a 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.
Event or Problem Description
Patient visited office and x-rays revealed an asymmetric joint space and supposed tibial baseplate fracture with poly wear.Patient had revision surgery.

• Brand Name: TRIATHLON PRIM CEM FXD BPLT #5
• 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: 19257847
• Report Number: 0002249697-2024-00692
• Device Sequence Number: 6680240
• Product Code: MBH
• UDI-Device Identifier: 07613327041057
• UDI-Public: 07613327041057
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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 Expiration Date: 10/31/2017
• Device Catalogue Number: 5520B500
• Device Lot Number: EA9JM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: 07/21/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2012
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 130 KG