MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE FEMUR; CEMENTED FEMORAL COMPONENT

Catalog Number	02.12.0003L
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 18 december 2018 the patient matched department analyzed the case: our analysis of the myknee process of this case found no deviations from the standard procedures.Each step has been performed correctly.Batch reviews performed on 28 december 2018: lot 142053: (b)(4) items manufactured and released on 28 april 2014.Expiration date: 2019-03-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Gmk sphere pe tibial insert code 02.12.0310fl lot.141791 (k121416): (b)(4) items manufactured and released on 06 june 2014.Expiration date: 2019-04-30.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Gmk tibial tray code 02.07.1203l lot.142697 (k090988): (b)(4) items manufactured and released on 02 july 2014.Expiration date: 2019-05-31.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.On 02 january 2019 the medical affairs director made the following analysis: revision of primary tka after 4.4 years.According to report, the cause for revision is pain and instability.The low-quality xrays do not allow any further analysis.Secondary instability may be due to progress of disease or to secondary ligament laxity.We could not see, probably because of image quality, radiographic signs of mobilization.No conclusion can be drawn as to the causes of this reintervention.
Event or Problem Description
Revision surgery due to pain and instability 4 years and 4 months after the primary surgery.All the components were revised.

• Brand Name: GMK SPHERE FEMUR
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8208010
• Report Number: 3005180920-2018-01047
• Device Sequence Number: 276520
• Product Code: JWH
• UDI-Device Identifier: 07630030825811
• UDI-Public: 07630030825811
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 01/02/2019

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: 03/31/2019
• Device Catalogue Number: 02.12.0003L
• Device Lot Number: 142053
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 01/02/2019
• 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: 69 YR
• Patient Weight: 80