MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L

Catalog Number	02.12.T3I4L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 may 2018.Lot 165027: (b)(4) items manufactured and released on 08 november 2016.Expiration date: 2021-10-27 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 insert fixed sphere flex size 4/13 mm l reference 02.12.0413fl (k140826) lot 154371: (b)(4) items manufactured and released on 21 september 2015.Expiration date: 2020-08-31.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.Gmk-sphere patella resurfacing size 2 reference 02.07.0034rp (k090988) lot 166108: (b)(4) items manufactured and released on 25 november 2016.Expiration date: 2021-11-09 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 femoral component sphere cemented size 5 l reference 02.12.0005l (k121416) lot 165986: (b)(4) items manufactured and released on 23 november 2016.Expiration date: 2021-11-13 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 2 months after primary the surgeon revised the patient for a infection.All the device replaced successfully after a period with a spacer implanted.Pathogen not available.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L
• Common Device Name: TIBIAL TRAY FIXED CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7540697
• Report Number: 3005180920-2018-00355
• Device Sequence Number: 13927935
• Product Code: JWH
• UDI-Device Identifier: 07630030827136
• UDI-Public: 07630030827136
• Combination Product (Y/N): N
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2018

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: 10/27/2021
• Device Catalogue Number: 02.12.T3I4L
• Device Lot Number: 165027
• 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: 04/24/2018
• Initial Report FDA Received Date: 05/24/2018
• 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: 61 YR