MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 R; FEMORAL COMPONENT CEMENTED

Catalog Number	02.12.0006R
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 october 2018; lot 172585: (b)(4) items manufactured and released on 21 october 2015.Expiration date: 2020-10-06 no a;nomalies 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 tray fixed cemented # 5 r reference 02.07.1205r (k090988); lot 160024: (b)(4) items manufactured and released on 09 march 2016 expiration date: 2021-02-27; 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
Cement didn't adhere to implants.The type of cement used is palacos r.Additional comment performed by surgeon: apparently a surgeon has revised two other patients of mine over the last year or so that were both medacta knees.In both of those cases there was no adherence of cement to the metal components.From what i understand, one of the knees was revised because of mid flexion instability and the other one had incompetence of the medial collateral ligament.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 R
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7999378
• Report Number: 3005180920-2018-00815
• Device Sequence Number: 1311740
• Product Code: JWH
• UDI-Device Identifier: 07630030825880
• UDI-Public: 07630030825880
• 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: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2018

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: 10/06/2020
• Device Catalogue Number: 02.12.0006R
• Device Lot Number: 154712
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 10/24/2018
• 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: 56 YR