MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TC PRIM TIBIAL INSERT TC CR STAND 8/13; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number 25338

Device Problems Break (1069); Component Missing (2306); Delamination (2904); Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 04/07/2016

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported that revision surgery was performed due to a worn and damaged insert.No evidence of infection was present.The explanted part reportedly had significant delamination and pitting in the medial compartment and the posterior lateral corner.The posterior lateral corner was also damaged with the posterior lip in the corner missing.The initial date of surgery was in 2008.

• Brand Name: TC PRIM TIBIAL INSERT TC CR STAND 8/13
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: claudia odoy ; 0628320660
• MDR Report Key: 5596795
• MDR Text Key: 43276525
• Report Number: 9613369-2016-00016
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2009
• Device Model Number: 25338
• Device Catalogue Number: 75006040
• Device Lot Number: 0211.13.4800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2016
• Date Device Manufactured: 04/11/2002
• 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