MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-UNI ANATOMICAL FEMORAL COMPONENT CEMENTED SIZE 2 RM/LL; KNEE FEMORAL CEMENTED COMPONENT

Catalog Number	02.08.302RMLL
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	10/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 november 2018.Lot 155449: (b)(4) items manufactured and released on 12 november 2015.Expiration date: 2020-10-28.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.Additional component revised: gmk-uni 02.08.Ct2.08.Rmll tibial component full pe #2 8mm rm-ll (not marketed in us) lot 154878: (b)(4) items manufactured and released on 12 november 2015.Expiration date: 2020-08-17.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.Preliminary investigation performed by r&d knee manager: revision surgery after 2 years from primary surgery for allergy and sudden deviation of implant set-up.Some residual cement can be seen on the internal surface of the femoral component and on the distal surface of the full pr insert.Some scratches are present both on the femur and the tibial components most likely caused during the attempt to explant the implants.There is no reason to suppose the event is related to a faulty device.Visual inspection performed by r&d knee manager: visual inspection confirms what already stated during preliminary investigation.Some residual cement can be seen on the internal surface of the femoral component and on the distal surface of the full pe insert.Some scratches are present both on the femur and the tibial components most likely caused during the attempt to explant the implants.Articular surface of the tibia component regularly worn out after 2 years from primary implantation.There is no reason to suppose the event is related to a faulty device.Clinical evaluation performed by medical affairs director: 2 years after primary cemented uka the patient was revised.From the radiographs, a progression of the disease can be surmised, which is probably the main reason for transforming the uka to a tka.According to report, the patient suffered from allergy during the first 6 months, but this problem must have been overcome.It is impossible for us to tell whether the suboptimal orientation of the components which is visible in the pre-revision xrays is due to allergic reaction.However, there is no reason to suspect that a faulty device is responsible.
Event or Problem Description
About 2 years and 4 months after primary the surgeon revised the patient for allergy.All devices revised.The surgery was completed successfully with good stability and satisfactory balancing.

• Brand Name: GMK-UNI ANATOMICAL FEMORAL COMPONENT CEMENTED SIZE 2 RM/LL
• Common Device Name: KNEE FEMORAL CEMENTED COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8098871
• Report Number: 3005180920-2018-00932
• Device Sequence Number: 11243675
• Product Code: HSX
• UDI-Device Identifier: 07630030879104
• UDI-Public: 07630030879104
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K161741
• 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): 11/22/2018

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: 10/28/2020
• Device Catalogue Number: 02.08.302RMLL
• Device Lot Number: 155449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/22/2018
• 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 Weight: 80