MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/17 MM L

Catalog Number	02.12.0417FL
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	09/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 october 2018; lot 153758: (b)(4) items manufactured and released on 12 novemebr 2015.Expiration date: 2022-09-24; 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 166110: (b)(4) items manufactured and released on 23 november 2016.Expiration date: 2021-11-10; 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.
Event or Problem Description
Revision surgery due to laxity 1 year and 2 months after the primary surgery.The surgeon swapped the poly and the patella resurfacing (left knee).The patella was not well fixed.Same patient of mdr 2018-00750.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/17 MM L
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7938079
• Report Number: 3005180920-2018-00753
• Device Sequence Number: 16720755
• Product Code: JWH
• UDI-Device Identifier: 07630030826658
• UDI-Public: 07630030826658
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2018

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: 09/24/2022
• Device Catalogue Number: 02.12.0417FL
• Device Lot Number: 153758
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 10/05/2018
• 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
• Patient Age: 70 YR