MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX #6/10 MM LEFT

Catalog Number	02.12.0610FL
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 14 june 2017 the patient match department reviewed the planning of this case and commented as follows: our analysis of the planning process of this case found no deviations from the standard procedures.Each step has been performed correctly.The problem mentioned in the complaint (detachment of the fixating screw) is, anyway, not imputable to the planning process.No extra-analysis is possible, since no x-ray is available.Batch review performed on 26 june 2017.Lot 163060: (b)(4) items manufactured and released on 04 august 2016.Expiration date: 2021-07-20.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.Not available.
Event or Problem Description
The patient came in complaining of pain.The cause of the pain in unknown.The surgeon swapped the poly.The surgery was completed successfully.The surgeon stated that nothing was visible on the x-rays, somehow the knee stretched out and the poly is to be upsized from a 10 to a 17 in order for the knee to become stable again.X-rays and explants are not available.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED FLEX #6/10 MM LEFT
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6669346
• Report Number: 3005180920-2017-00339
• Device Sequence Number: 1761099
• Product Code: JWH
• UDI-Device Identifier: 07630030826931
• UDI-Public: 07630030826931
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/27/2017

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: 07/20/2021
• Device Catalogue Number: 02.12.0610FL
• Device Lot Number: 163060
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2017
• Initial Report FDA Received Date: 06/27/2017
• 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