MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 5/12MM; POSTERIORLY STABILIZED TIBIAL KNEE INSERT

Model Number	02.07.0512PSF
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary tkr on (b)(6) 2011.On the (b)(6) 2013 the patient had a revision surgery with liner swap, the reason of this revision is unknown.At 8 years and 8 months form the first revision the patient had a new revision surgery for liner fixation screw breakage.The surgeon swapped successfully the patient tibial tray and liner.The patient had a fell on his knee on (b)(6) 2018.
Additional Manufacturer Narrative
Batch review performed on 31 january 2022: lot 121959: (b)(4) items manufactured and released on 25-sept-2012.Expiration date: 2017-08-31.No anomalies found related to the problem.To date, 24 items of the same lot have been sold without any similar reported event since 1-1-2013.Clinical evaluation performed by medical affairs director.About 9 years after primary cemented tka the inlay fixation screw is found broken and loose in the joint.According to report, a light trauma occurred two years before finding the loose/broken screw; the relevance of this event is doubtful.A radiograph supplied and dated october 2020 shows the screw having backed out slightly from its optimal seating, which evidently creates an unfavourable mechanical situation that makes fracture more likely.Self back-out of the inlay fixation screws is possible and it is often caused by insufficient torque applied during primary surgery.However, when this is the case, the back-out phenomenon takes place within the first two years.Such a late occurrence is extremely rare and no sufficient evidence has been collected so far that allows us to offer a possible explanation.
Additional Manufacturer Narrative
Batch review performed on 31 january 2022: lot 121959: (b)(4) items manufactured and released on 25-sept-2012.Expiration date: 2017-08-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since 1-1-2013.Clinical evaluation performed by medical affairs director.About 9 years after primary cemented tka the inlay fixation screw is found broken and loose in the joint.According to report, a light trauma occurred two years before finding the loose/broken screw; the relevance of this event is doubtful.A radiograph supplied and dated october 2020 shows the screw having backed out slightly from its optimal seating, which evidently creates an unfavourable mechanical situation that makes fracture more likely.Self back-out of the inlay fixation screws is possible and it is often caused by insufficient torque applied during primary surgery.However, when this is the case, the back-out phenomenon takes place within the first two years.Such a late occurrence is extremely rare and no sufficient evidence has been collected so far that allows us to offer a possible explanation.
Event or Problem Description
The patient had a primary tkr on (b)(6) 2011.On the (b)(6) 2013 the patient had a revision surgery with liner swap, the reason of this revision is unknown.At 8 years and 8 months form the first revision the patient had a new revision surgery for liner fixation screw breakage.The surgeon swapped successfully the patient tibial tray and liner.The patient had a fell on his knee on (b)(6) 2018.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 5/12MM
• Common Device Name: POSTERIORLY STABILIZED TIBIAL KNEE INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13575834
• Report Number: 3005180920-2022-00127
• Device Sequence Number: 4368928
• Product Code: JWH
• UDI-Device Identifier: 07630030818325
• UDI-Public: 07630030818325
• 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: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2022

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: 08/31/2017
• Device Model Number: 02.07.0512PSF
• Device Catalogue Number: 02.07.0512PSF
• Device Lot Number: 121959
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male