MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM BEAD PA SZE3 BP; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number	5526B300
Medical Device Problem Codes	Malposition of Device (2616); Positioning Problem (3009)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding malposition involving a triathlon baseplate was reported.The event was confirmed through clinician review of the medical records provided.Method & results: device evaluation and results: not performed as no product was returned for evaluation.Medical records received and evaluation: the medical review indicated: baseplate malposition in excessive posterior tibial slope and excessive proximal tibial bone removal requiring implantation of a very thick 19-mm cr bearing have rendered the pcl dysfunctional with severe instability as outcome requiring revision where the problem was one partly solved by implantation of a thicker 22-mm cs bearing.Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: the medical review indicated that baseplate malposition in excessive posterior tibial slope and excessive proximal tibial bone removal requiring implantation of a very thick 19-mm cr bearing have rendered the pcl dysfunctional with severe instability as outcome requiring revision where the problem was one partly solved by implantation of a thicker 22-mm cs bearing.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Knee revision due to instability.Update based on medical review: baseplate malposition in excessive posterior tibial slope and excessive proximal tibial bone removal have rendered the pcl dysfunctional with severe instability.

• Brand Name: TRIATHLON PRIM BEAD PA SZE3 BP
• Common Device Name: KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7805553
• Report Number: 0002249697-2018-02638
• Device Sequence Number: 11048467
• Product Code: MBH
• UDI-Device Identifier: 07613327041347
• UDI-Public: 07613327041347
• 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: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/22/2018

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: 10/31/2013
• Device Catalogue Number: 5526B300
• Device Lot Number: SJ66S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 08/22/2018
• 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: 68 YR
• Patient Weight: 39