MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM BEAD PA SZE4 BP; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5526B400
Medical Device Problem Codes	Unstable (1667); Malposition of Device (2616)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding malposition involving a triathlon baseplate was reported.The event was confirmed following a clinician review of medical records provided.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: [.] the tibial baseplate has major and complex malposition with an excessive posterior slope of 12° but also malalignment in the ap plane with some 8° valgus plus 2-mm lateral shift of the baseplate.Stable bone ingrowth condition of the baseplate.Overall knee alignment is still adequate with 6°.No other clinical, radiological or explant information was provided.[.] conclusion of assessment: baseplate malposition in excessive posterior tibial slope of 12° with additional 8° valgus deformity have contributed to flexion instability of the knee arthroplasty with consequent polyethylene wear and clinical symptoms requiring revision surgery.Does the review identify any procedural related factors that contributed to the event? baseplate malposition in excessive posterior tibial slope of 12° plus 8° valgus malalignment.Minor malposition of femoral component in posterior direction.Does the review identify any patient related factors that contributed to the event? high activity level may be considered a secondary factor to increase the adverse effects of instability.Does the review identify any device related factors that caused or contributed to the adverse event? no device-related factors are associated with any of the implanted devices.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: a clinician review of the provided medical records states the following: "baseplate malposition in excessive posterior tibial slope of 12° with additional 8° valgus deformity have contributed to ]lexion instability of the knee arthroplasty with consequent polyethylene wear and clinical symptoms requiring revision surgery." no further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Device not returned.
Event or Problem Description
Knee revision instability due to poly wear.Update 24 may 2019: conclusion of the medical review dated 20 may 2019 states: baseplate malposition in excessive posterior tibial slope of 12° with additional 8° valgus deformity have contributed to flexion instability of the knee arthroplasty with consequent polyethylene wear and clinical symptoms requiring revision surgery.
Additional Manufacturer Narrative
An event regarding malposition involving a triathlon baseplate was reported.The event was confirmed following a clinician review of medical records provided method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: [.] the tibial baseplate has major and complex malposition with an excessive posterior slope of 12° but also malalignment in the ap plane with some 8° valgus plus 2-mm lateral shift of the baseplate.Stable bone ingrowth condition of the baseplate.Overall knee alignment is still adequate with 6°.No other clinical, radiological or explant information was provided.[.] conclusion of assessment baseplate malposition in excessive posterior tibial slope of 12° with additional 8° valgus deformity have contributed to flexion instability of the knee arthroplasty with consequent polyethylene wear and clinical symptoms requiring revision surgery.Does the review identify any procedural related factors that contributed to the event? - baseplate malposition in excessive posterior tibial slope of 12° plus 8° valgus malalignment - minor malposition of femoral component in posterior direction does the review identify any patient related factors that contributed to the event? - high activity level may be considered a secondary factor to increase the adverse effects of instability.Does the review identify any device related factors that caused or contributed to the adverse event? - no device-related factors are associated with any of the implanted devices.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: a clinician review of the provided medical records states the following: "baseplate malposition in excessive posterior tibial slope of 12° with additional 8° valgus deformity have contributed to flexion instability of the knee arthroplasty with consequent polyethylene wear and clinical symptoms requiring revision surgery.".
Event or Problem Description
Knee revision instability due to poly wear.Update 24 may 2019: conclusion of the medical review dated 20 may 2019 states: baseplate malposition in excessive posterior tibial slope of 12° with additional 8° valgus deformity have contributed to flexion instability of the knee arthroplasty with consequent polyethylene wear and clinical symptoms requiring revision surgery.

• Brand Name: TRIATHLON PRIM BEAD PA SZE4 BP
• 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: 8716085
• Report Number: 0002249697-2019-02309
• Device Sequence Number: 1844431
• Product Code: MBH
• UDI-Device Identifier: 07613327041354
• UDI-Public: 07613327041354
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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): 06/27/2019

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: 02/28/2017
• Device Catalogue Number: 5526B400
• Device Lot Number: S8C6Y
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 06/27/2019
• 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: 72 YR
• Patient Weight: 82