MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 1+ R; FEMORAL COMPONENT CEMENTED

Catalog Number	02.12.0021R
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 august 2019: lot 156291: (b)(4) items manufactured and released on 19-feb-2016.Expiration date: 2021-01-05.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.Clinical evaluation performed by medical affairs director: two years after primary cemented tka, the surgeon revised the 10 mm-thick poly to a 17 mm.This may induce to think that the cause for pain was secondary instability, which is a known possible complication after tka, often caused by secondary stretching of ligaments or loss of tone of soft tissues surrounding the joint.No other evident causes for pain could be determined with the information at hand.Additional implants involved in the event, batch review performed on 16 august 2019.Gmk-sphere 02.07.1201r gmk tibial tray cemented right s1 (k090988) lot.164890 lot 164890: (b)(4) items manufactured and released on 27-set-2016.Expiration date: 2021-01-05.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 02.12.0110fr sphere insert flex right 10 mm s1 (k121416) lot.154761 lot 154761: (b)(4) items manufactured and released on 14-gen-2016.Expiration date: 2020-12-14.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 performed after 2 years and 2 months from the primary due to pain and the cause of pain is unknown.The surgeon revised the femoral component, tibial tray and insert (10 mm exchanged with liner 17 mm) successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 1+ R
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8959262
• Report Number: 3005180920-2019-00731
• Device Sequence Number: 14093984
• Product Code: JWH
• UDI-Device Identifier: 07630030862458
• UDI-Public: 07630030862458
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2019

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: 01/05/2021
• Device Catalogue Number: 02.12.0021R
• Device Lot Number: 156291
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 09/04/2019
• 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