MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR CEMENTED PS SIZE 2NARROW / LEFT; CEMENTED FEMUR

Catalog Number	02.07.2212L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 september 2018.Lot 143535: (b)(4) items manufactured and released on 16 july 2014.Expiration date: 2019-06-30 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.Others devices involved: tibial insert ps fixed size 2/10mm; reference 02.07.0210psf; (k090988).Lot 174622: (b)(4) items manufactured and released on 14 august 2017.Expiration date: 2022-07-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with a similar reported event.Tibial tray fixed cemented size 2 l; reference 02.07.1202l; (k090988).Lot 170414: (b)(4) items manufactured and released on 30 may 2017.Expiration date: 2022-05-16 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.Patella resurfacing size 1; reference 02.07.0033rp; (k090988).Lot 171999: (b)(4) items manufactured and released on 25 july 2017.Expiration date: 2022-07-02 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 infection.The surgery was completed successfully.

• Brand Name: GMK-PRIMARY FEMUR CEMENTED PS SIZE 2NARROW / LEFT
• Common Device Name: CEMENTED FEMUR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7845330
• Report Number: 3005180920-2018-00658
• Device Sequence Number: 1143818
• Product Code: JWH
• UDI-Device Identifier: 07630030820946
• UDI-Public: 07630030820946
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2018

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: 06/30/2019
• Device Catalogue Number: 02.07.2212L
• Device Lot Number: 143535
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 09/05/2018
• 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