MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/14 MM L

Catalog Number	02.12.0214FL
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 january 2018 lot 156304: (b)(4) items manufactured and released on 04 april 2016.Expiration date: 2021-03-10 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Tibial insert fixed sphere flex #2/14 mm l reference 02.12.0214fl (k121416) lot 163355: (b)(4) items manufactured and released on 12 sept 2016.Expiration date: 2021-08-30 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision surgery performed due to superficial infection at the incision site, that communicate with the joint, 22 days after primary.The surgeon washed out the infection and replaced the poly with a size2x14mmm left poly.The surgeon inserted the poly incorrectly (lot 163355), at which time the locking mechanism was damaged.An insert from another lot was opened and inserted without further delay.

• Brand Name: TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/14 MM L
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7221025
• Report Number: 3005180920-2018-00005
• Device Sequence Number: 2248950
• Product Code: JWH
• UDI-Device Identifier: 07630030826214
• UDI-Public: 07630030826214
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/26/2018

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: 03/10/2021
• Device Catalogue Number: 02.12.0214FL
• Device Lot Number: 156304
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2017
• Initial Report FDA Received Date: 01/26/2018
• 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: Required Intervention
• Patient Age: 51 YR