MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #3L; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5517F301
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate the devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the reported lot.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Patient needs a knee revision due to ¿instability¿.
Event or Problem Description
Patient needs a knee revision due to ¿instability¿.Update: as per clinician review: baseplate malposition in excessive posterior tibial slope with choice for cr type of components in a knee with long standing stability problems has contributed to early failure of the triathlon cr arthroplasty with recurrent instability requiring exchange to triathlon ts.
Additional Manufacturer Narrative
An event regarding revision due to instability involving a triathlon femoral component 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 with choice for cr type of components in a knee with long standing stability problems has contributed to early failure of the triathlon cr arthroplasty with recurrent instability requiring exchange to triathlon ts.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 with choice for cr type of components in a knee with long standing stability problems has contributed to early failure of the triathlon cr arthroplasty with recurrent instability requiring exchange to triathlon ts.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: TRIATHLON P/A CR BEADED #3L
• 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: 7536346
• Report Number: 0002249697-2018-01540
• Device Sequence Number: 283615
• Product Code: MBH
• UDI-Device Identifier: 07613327040920
• UDI-Public: 07613327040920
• 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: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2018

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: 06/30/2021
• Device Catalogue Number: 5517F301
• Device Lot Number: A6N4T
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 05/23/2018
• Supplement Report FDA Received Date: 08/14/2018
• 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: Other
• Patient Age: 59 YR
• Patient Weight: 66