MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE PATELLA RESURFACING SIZE 4

Catalog Number	02.07.0036RP
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Update 18 september 2018: pathogen not available.Lot 164135: (b)(4) items manufactured and released on 21 september 2016.Expiration date: 2021-09-07.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.Other devices involved.Reference 02.12.0512fr (k121416)tibial insert fixed sphere flex #5/12 mm r; lot 162640: (b)(4) items manufactured and released on 28 july 2016.Expiration date: 2021-07-17; 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.Reference 02.12.0025r (k140826) femoral component sphere cemented size 5+ r; lot 147699: (b)(4) items manufactured and released on 12 january 2015.Expiration date: 2019-11-30; 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.Reference 02.07.1205r (k090988) tibial tray fixed cemented size 5 r; lot 153500: (b)(4) items manufactured and released on 20 august 2015.Expiration date: 2020-06-30; no anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient had a primary surgery on (b)(6) 2015.The patient came in due to signs of infection.The patient was septic.The surgeon washed out the knee and swapped the poly and revised the patella.Mdr (2017-00383) was filed.On (b)(6) 2018 the patient was revised again due to infection, pathogen unknown.The surgeon removed all hardware and implanted a spacer.

• Brand Name: GMK-SPHERE PATELLA RESURFACING SIZE 4
• Common Device Name: PATELLA RESURFACING
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7897535
• Report Number: 3005180920-2018-00709
• Device Sequence Number: 11189403
• Product Code: JWH
• UDI-Device Identifier: 07630030815775
• UDI-Public: 07630030815775
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K113571
• 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): 09/21/2018

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: 09/07/2021
• Device Catalogue Number: 02.07.0036RP
• Device Lot Number: 164135
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 09/21/2018
• 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