MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM BEAD PA SZE5 BP; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5526B500
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Injury (2348); Limited Mobility Of The Implanted Joint (2671)
Date of Event	07/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding polyethylene wear of the tibial insert was reported, upon review of the provided medical records by a clinician malposition of the triathlon baseplate was alleged.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 (it remains implanted).Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: "review of x-rays reveal the tibial component is in 5 degrees in varus and 5 degrees in posttrial slope.To more accurately determine alignment, full length x-rays would be required." 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: an event regarding polyethylene wear of the tibial insert was reported (and confirmed).Review of provided medical records reveal the tibial component is in 5 degrees in varus and 5 degrees in posterial slope.Malposition cannot be confirmed as to more accurately determine alignment, full length x-rays would be required.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
Knee revision due to poly wear.Update 28 nov 2019: additional comment provided by clinician: "review of x-rays reveal the tibial component is in 5 degrees in varus and 5 degrees in posttrial slope.To more accurately determine alignment, full length x-rays would be required.".

• Brand Name: TRIATHLON PRIM BEAD PA SZE5 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: 9520426
• Report Number: 0002249697-2019-04116
• Device Sequence Number: 516497
• Product Code: MBH
• UDI-Device Identifier: 07613327041378
• UDI-Public: 07613327041378
• 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: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/26/2019

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: 12/31/2017
• Device Catalogue Number: 5526B500
• Device Lot Number: EBPCD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2019
• Initial Report FDA Received Date: 12/26/2019
• 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: 46 YR
• Patient Weight: 86