MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S6; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5536B600
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/03/2019
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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient's left knee was revised due to a broken tibial baseplate.Intra- operatively, surgeon reported the existence of a hole in the patient's bone directly under the place where the baseplate broke (cause and nature of the hole was not reported).A size 6 baseplate and 6x9 cs insert were revised to a size 6 universal baseplate with a 6x16 cs insert.
Event or Problem Description
It was reported that the patient's left knee was revised due to a broken tibial baseplate.Intra- operatively, surgeon reported the existence of a hole in the patient's bone directly under the place where the baseplate broke (cause and nature of the hole was not reported).A size 6 baseplate and 6x9 cs insert were revised to a size 6 universal baseplate with a 6x16 cs insert.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a triathlon baseplate was reported.The event was confirmed by product inspection.Method & results: device evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 25-oct-2019.This inspection indicated there was damage consistent with the implantation/explantation process and burnishing was observed on the main baseplate body fracture surface.Material evaluation was completed and indicated the following comments: striations consistent with fatigue fracture were observed on the baseplate fracture surface.The approximate fracture origin occurred at multiple sites on the proximal surface and propagated to the distal surface.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: ¿no clinical or past medical history, no examination of explanted components, and no prerevision x-rays of the left knee are available.In this very large male patient, the description of a cystic lesion below the posteromedial tibial component likely resulted in cyclic loading at the junction of the unsupported portion of the tibial component with the ingrown portion, leading to inevitable fatigue fracture.Examination of the explanted components would confirm this mechanism and rule out factors associated with implant design, manufacturing or materials.¿ device 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 reported lot.Conclusion: a clinician review of the provided medical records states the following; no clinical or past medical history, no examination of explanted components, and no prerevision x-rays of the left knee are available.In this very large male patient, the description of a cystic lesion below the posteromedial tibial component likely resulted in cyclic loading at the junction of the unsupported portion of the tibial component with the ingrown portion, leading to inevitable fatigue fracture.Examination of the explanted components would confirm this mechanism and rule out factors associated with implant design, manufacturing or materials.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, clinical reports, and pre-revision x-rays are needed to fully investigate the event.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: TRITANIUM BPLATE TRIATHLON S6
• 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: 9135239
• Report Number: 0002249697-2019-03346
• Device Sequence Number: 3185555
• Product Code: MBH
• UDI-Device Identifier: 07613327041514
• UDI-Public: 07613327041514
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2019

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: 11/30/2022
• Device Catalogue Number: 5536B600
• Device Lot Number: CTD20710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 12/04/2019
• 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; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 129