MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T4-I3 R

Catalog Number	02.12.T4I3R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information received on (b)(6) 2018 by sales representative the second stage revision has not happened yet.The patient refuses to release his results about whether it is infection or not.The surgeon indicated that the second step revision may be in roughly 6 months.Clinical evaluation performed by medical affairs director on (b)(6) 2018 few months after primary cemented tka the patient was revised for pain.Alignment of the components looked suboptimal at static xrays in uncertain patient posture, but during revision surgery infection was suspected and a two-stage revision undertaken.From the information available, there is no indication of a faulty device and the most likely cause for the adverse event seems to be infection.Investigation performed by patient match department on (b)(6) 2018 our analysis of the my knee process of this case found no deviations from the standard procedures.Each step has been performed correctly.Batch review performed on (b)(6) 2018 lot 163353: (b)(4) items manufactured and released on 26 july 2016.Expiration date: 2021-06-13 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 devices involved: reference (b)(4) (k121416) tibial insert fixed sphere flex size 3/10 mm r lot 172812: (b)(4) items manufactured and released on 13 july 2017.Expiration date: 2022-06-29 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.Reference (b)(4) (k140826) femoral component sphere cemented size 3+ r lot 171830: (b)(4) items manufactured and released on 19 july 2017.Expiration date: 2022-07-11 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
The tibial tray was found internally rotated 8 months after primary.Surgeon planned to take it out and realign the base plate for better knee alignment.During revision the surgeon suspected infection as there was synovial fluid behind the cement.The femoral bone was also really soft.He decided to do a 2 stage revision: all the implants were removed and the specimens sent for analysis.He temporarily put the femur back in with antibiotic cement and cemented (temporarily) the poly.The surgeon also voiced that the femur component seemed more internally rotated and the tibial component also malrotated.
Additional Manufacturer Narrative
Update october 17, 2018.The case is not going to be revised with medacta products according to the secretary.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T4-I3 R
• Common Device Name: TIBIAL TRAY FIXED CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7804986
• Report Number: 3005180920-2018-00627
• Device Sequence Number: 16407195
• Product Code: JWH
• UDI-Device Identifier: 07630030827167
• UDI-Public: 07630030827167
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2018

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: 06/13/2021
• Device Catalogue Number: 02.12.T4I3R
• Device Lot Number: 163353
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 11/15/2018
• 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: 69 YR