MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG RT-PLUS TIBIAL INSERT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Device Problem Naturally Worn (2988)

Patient Problem Joint Disorder (2373)

Event Date 10/02/2017

Event Type  Injury  

Event Description

User report (b)(6) reported through bfarm - revision surgery due to instability of the rt-plus modular knee prosthesis and inlay-wear with exchange of the rt-plus insert.

• Brand Name: RT-PLUS TIBIAL INSERT
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 6340 ; SZ 6340
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau 5001 ; SZ 5001
• Manufacturer Contact: markus poettker
• MDR Report Key: 6939614
• MDR Text Key: 89235140
• Report Number: 9613369-2017-00055
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K021714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2017
• 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