MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG RT PLUS MOD. FEM. COMP RT SZ 8 (CUSTOM) PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED,

Catalog Number 71420574

Device Problems Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 11/26/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case (b)(4).

Event Description

It was reported that, revision surgery was performed one year after primary procedure due to ptg infection. The information about which device(s) caused the infection was not initially provided.

• Brand Name: RT PLUS MOD. FEM. COMP RT SZ 8 (CUSTOM)
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED,
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau TN CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau TN CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11099933
• MDR Text Key: 224521742
• Report Number: 9613369-2020-00278
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K023667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 71420574
• Device Lot Number: I1822120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/26/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/31/2020 Patient Sequence Number: 1

Treatment

71420574/GNS II RESURF PAT 29MM/19AM19414; UNKN ORTHOPAEDIC RECONSTRUCTION DEV; UNKN ORTHOPAEDIC RECONSTRUCTION DEV; UNKN ORTHOPAEDIC RECONSTRUCTION DEV; UNKN ORTHOPAEDIC RECONSTRUCTION DEV