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

Device Problems Malposition of Device (2616); Positioning Problem (3009)

Patient Problem Injury (2348)

Event Date 05/15/2018

Event Type  Injury  

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 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
• Type of Device: KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7805553
• MDR Text Key: 117881888
• Report Number: 0002249697-2018-02638
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327041347
• UDI-Public: 07613327041347
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 39