MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG RT-PLUS MODULAR FEMORAL COMPONENT LEFT 8 CEMENTED; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 24328

Device Problems Metal Shedding Debris (1804); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Toxicity (2333)

Event Date 01/26/2017

Event Type  Injury  

Event Description

Revision surgery due to implant failure 18 months after initial implantation in (b)(6) 2015.Intraoperatively, a massive metallosis was found in the area of the notch of the pivot axis due to knee hyperextension.

Manufacturer Narrative

[(b)(4)].

• Brand Name: RT-PLUS MODULAR FEMORAL COMPONENT LEFT 8 CEMENTED
• 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 ; 0628320660
• MDR Report Key: 6349184
• MDR Text Key: 67962395
• Report Number: 9613369-2017-00011
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K023667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 24328
• Device Catalogue Number: 75005557
• Device Lot Number: I1502161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2015
• 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
• Treatment: RT-PLUS MODULAR STEM CONICAL, PART 75005514,LOT NI; RT-PLUS MODULAR STEM CONICAL, PART 75005515,LOT NI; RT-PLUS MODULAR TIBIAL COMP, PART 75005561, LOT NI; RT-PLUS TIBIAL INSERT, PART 75005485, LOT D1505352
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR