MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3+ R; CEMENTED FEMORAL COMPONENT

Model Number	01.13.107L
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	05/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regualtory affairs department on 10 june 2020: lot 1900325: (b)(4) items manufactured and released on 10-may-2019.Expiration date: 2024-04-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with no other similar reported event.
Event or Problem Description
The patient came in 7 months after the primary surgery reporting discomfort while ambulating.During a post-op visit the surgeon observed that the femoral component was in 9° valgus.There was zero degrees of varus planned, probably it is the cause of the positioning of the implant during the primary surgery.The patient was mechanically aligned.The surgeon revised the femoral component and poly from a sphere to a semi-constrained.Tibial component was not revised.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3+ R
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10157890
• Report Number: 3005180920-2020-00348
• Device Sequence Number: 11469056
• Product Code: JWH
• UDI-Device Identifier: 07630030803277
• UDI-Public: 07630030803277
• 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: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/16/2020

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: No Information
• Device Expiration Date: 04/30/2024
• Device Model Number: 01.13.107L
• Device Catalogue Number: 02.12.0023R
• Device Lot Number: 1900325
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 06/16/2020
• 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: 80 YR