MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L; FEMORAL COMPONENT CEMENTED

Catalog Number	02.12.0004L
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	04/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 may 2018; lot 147683: (b)(4) items manufactured and released on 13 january 2015.Expiration date: 2019-11-30; 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.Other device involved: gmk-sphere tibial tray fixed cemented size t3-i4 l reference 02.12.T3i4l (k121416i); lot 148422: (b)(4) items manufactured and released on 17 february 2015.Expiration date: 2020-01-31.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 visual inspection performed by r&d product manager on 30 april 2018; revision surgery after 2 years from primary tka for loosening of both the tibial and femoral components.No residual cement can be seen on the internal surfaces in contact with the bone of the femoral and the tibial components.This is something usual to be seen on explanted components, even if the cause of revision is not instability, loosening or mobilization.So, a cementation problem could be the cause of the event.The absence of cement on the internal surface is not an evidence of a faulty device justifying a lack of integration between the cement and the implant.Cementation problems are most likely linked to several factors not implant related.Tibial insert was found regularly worn out after 2 years from primary implantation.No other considerations relevant for the event can be done from visual inspection of the explanted components.Investigation performed by patient match department on 11 may 2018; our analysis of the my knee process of this case found no deviations from the standard procedures.Each step has been performed correctly.Clinical evaluation performed by medical affairs (b)(4) on 18 may 2018; knee revision surgery in a (b)(6) kg woman occurred 2 years after primary implantation.Radiographic image provided doesn't allow a proper clinical evaluation.The cement mantle around the tibial baseplate profile seems incomplete.According to the report, the components were easily removed suggesting no interdigitation of cement with the devices.This was noted on both femoral and tibial component, which suggests that a cementation problem occurred during surgery and hindered cement interdigitation.This is a rare occurrence, described in literature, and it is probably due to a problem related with the cement itself, or more likely its storage or transport, or even temperature or timing during surgery.
Event or Problem Description
Revision of tibial baseplate and femoral component due to loosening 2 years and 3 months after primary.Implants came off easily without any bone loss, the surgeon decided to revise both implants with gmk primary.

• Brand Name: FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7525806
• Report Number: 3005180920-2018-00333
• Device Sequence Number: 13859692
• Product Code: JWH
• UDI-Device Identifier: 07630030825835
• UDI-Public: 07630030825835
• 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: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/18/2018

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: 11/30/2019
• Device Catalogue Number: 02.12.0004L
• Device Lot Number: 147683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 05/18/2018
• 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: 67 YR