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	Pain (1994)
Date of Event	06/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 july 2018: lot 153123: (b)(4) items manufactured and released on 12 june 2015.Expiration date: 30.04.2020 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: reference 02.12.0003r (k121416) femoral component sphere cemented # 3 r lot.161657 lot 161657: (b)(4) items manufactured and released on 26 april 2016.Expiration date: 11.04.2021 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 on 20 july 2018: 1,5 years after primary cemented tka the patient needed revision.The radiographs supplied clearly show that the position of the components is most likely the cause of the problem.The alignment is not adequate and the tibial tray does not cover properly the tibial metaphysis.We have only one set of xray therefore we cannot tell if this position is the result of component migration or if it was a surgical decision.We have no data reporting any particular surgical strategy.There is no reason to suspect malfunctioning devices.
Event or Problem Description
Due to malpositioning of implants (primarily femoral component, but also tibial component), the patient suffered residual pain and needed a revision 1 year and 8 months after revision.

• 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: 7706402
• Report Number: 3005180920-2018-00531
• Device Sequence Number: 16326714
• Product Code: JWH
• UDI-Device Identifier: 07630030827167
• UDI-Public: 07630030827167
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/20/2018

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: 04/30/2020
• Device Catalogue Number: 02.12.T4I3R
• Device Lot Number: 153123
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2018
• Initial Report FDA Received Date: 07/20/2018
• 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: 63 YR
• Patient Weight: 76