MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R; CEMENTED FEMORAL COMPONENT

Catalog Number	02.12.0023R
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 september 2018; lot 171831: (b)(4) items manufactured and released on 31 july 2017.Expiration date: 2022-07-19; 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.Gmk sphere tibial tray fixed cemented size 3 r reference 02.07.1203r (k090988); lot 171151: (b)(4) items manufactured and released on 06 july 2017.Expiration date:.2022-06-20; 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 size 3/13 mm r reference 02.12.0313fr (k140826); lot 141417: (b)(4) items manufactured and released on 23 may 2014.Expiration date: 2019-03-31; 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
About 10 months after primary the surgeon revised the patient for knee instability probably due to a previous patellar tendon injury.

• Brand Name: FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7854958
• Report Number: 3005180920-2018-00666
• Device Sequence Number: 1980420
• Product Code: JWH
• UDI-Device Identifier: 07630030862380
• UDI-Public: 07630030862380
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/07/2018

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: 07/09/2022
• Device Catalogue Number: 02.12.0023R
• Device Lot Number: 171831
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 09/07/2018
• 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