MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR PS CEMENTED SIZE 5 L; CEMENTED FEMORAL COMPONENT

Model Number	02.07.2205L
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	05/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09-jun-2020: lot 134733: (b)(4) items manufactured and released on 07-nov-2013.Expiration date: 30.09.2018.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event since 2016.Additional implant involved: gmk-primary 02.07.1205l tibial tray fixed cemented size 5 l (k090988) lot.134840.Batch review performed on 09-jun-2020: lot 134840: (b)(4) items manufactured and released on 06-dec-2013.Expiration date: 31.10.2018.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2016.Additional implant involved: gmk-primary 02.07.0514sf tibial insert std fixed size 5 / 14 mm (k090988) lot.121960.Batch review performed on 09-jun-2020: lot 121960: (b)(4) items manufactured and released on 25-sep-2012.Expiration date: 31.08.2017.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2016.Preliminary investigation performed by r&d project manager revision surgery after 6 years from primary implantation due to pain and instability.Looking at the picture of the explanted components, we can't notice any alterations or anomalies of the devices occurred prior, during or after the implantation.There is no evidence that the event is caused by a faulty device.The event is most likely related to a malpositioning of the implant in the primary surgery or a change of patient's clinical scenario over time.Clinical evaluation performed by medical affairs director: 6 years after primary cemented tka, postero-stabilized, a revision is undertaken because of instability, pain, and malposition.We have no history of this case, hence we cannot determine if the instability and malposition were present since the immediate postoperative or intervened afterwards, either for component migration or progression of patient's illness.The partial radiographs do not allow full evaluation of component position, which appears to be rather uncommon, but there are not sufficient elements to make a hypotheses as to the reasons for this choice.The relevance of this position to the instability and pain are not determinable from the elements at hand.
Event or Problem Description
Revision surgery performed due to knee pain 6 years after the primary surgery.The knee was unstable in extension, flexion and medial rotation.

• Brand Name: GMK-PRIMARY FEMUR PS CEMENTED SIZE 5 L
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10137746
• Report Number: 3005180920-2020-00316
• Device Sequence Number: 19412990
• Product Code: JWH
• UDI-Device Identifier: 07630030820861
• UDI-Public: 07630030820861
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2020

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: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: 02.07.2205L
• Device Catalogue Number: 02.07.2205L
• Device Lot Number: 134733
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 06/10/2020
• 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: 57 YR
• Patient Weight: 112