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

Catalog Number	02.12.0023L
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	12/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2017 the patient match department reported the following investigation.Here is our comparison between the implanted femoral component and the validated planning: · the implanted size is the validated one.· the component has been implanted with slightly more flexum.Here is our comparison between the implanted tibia component and the validated.Planning: ·the implanted size is the validated one.·the entity of the cut is slightly lower than the planned 9.0 mm cut.·the component has been given slightly more slope than the planned 3.0°.·the component has been implanted with a slight residual valgus, whilst no residual deformity has been planned.Our analysis of the myknee process of this case found no deviations from the standard procedures.Each step has been performed correctly.Clinical evaluation performed by medical affairs on 22 december 2017: complete revision of cemented primary tkr after 1,5 years.The short-film radiograph supplied does not allow to evaluate alignment of the prosthesis in this valgus knee, which is per se a more challenging case.Some areas of radiolucency are visible both in the distal femur and proximal tibia, but their relation with reported pain cannot be demonstrated.The causes for this adverse event remain undetermined after clinical investigation with the elements at hand.Batch review performed on 29 december 2017 lot 160133: (b)(4) items manufactured and released on 23 february 2016.Expiration date: 2021-01-26 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 tibial tray fixed cemented # 3 l reference 02.07.1203l (k090988) lot.154002: (b)(4) items manufactured and released on 13 oct 2015.Expiration date: 2020-09-28 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 due to loosening (femoral and tibial component) 1 year and 8 months after primary.The surgeon revised all medacta components and re-implanted another company's product.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3+ L
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7153839
• Report Number: 3005180920-2017-00799
• Device Sequence Number: 1863677
• Product Code: JWH
• UDI-Device Identifier: 07630030862373
• UDI-Public: 07630030862373
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/29/2017

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: 01/26/2021
• Device Catalogue Number: 02.12.0023L
• Device Lot Number: 160133
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 12/29/2017
• 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
• Patient Age: 75 YR