MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR CEMENTED PS SIZE 4NARROW / RIGHT; KNEE FEMORAL COMPONENT CEMENTED

Catalog Number	02.07.2214R
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	09/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 13 october 2017 the patient match department provided a process review reporting as follows: our analysis of the planning process of this case found no deviations from the standard procedures.Each step has been performed correctly.On 19 october 2017 the medical affairs director performed a clinical evaluation and commented as follows: partial revision of primary cemented tka after 3 years.A fixed, ultra-congruent tibial baseplate was replaced with a thicker insert and a stemmed implant.The primary implantation appears to have very pronounced posterior slope of the tibial component and a lateral shift; these conditions may result in (posterior, probably) instability of the joint, depending on ligament conditions and patient activity and fitness.We have no information as to the conditions that led to this particular placement.There is no reason to suspect a faulty implant at the origin of the problem.Batch reviews performed on 17 october 2017.Lot 156165: (b)(4) items manufactured and released on 28 january 2016.Expiration date: 2021-01-16.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.Gmk-primary tibial insert ps fixed size 3/10mm, code 02.07.0310psf, lot.160590 (k090988) (b)(4) items manufactured and released on 24 may 2016.Expiration date: 2021-05-05.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.Gmk-primary tibial tray fixed cemented size 3 right, lot.164077 (k090988) (b)(4) items manufactured and released on 15 september 2016.Expiration date: 2021-09-06.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.On 20 october 2017 the r&d project manager performed a visual inspection of the explanted components and commented as follows: - femoral component: some residual cement can be noted on the internal surface of the femoral component, mainly in the distal part.Several dents and scratches can be noted on the articular surface of the component.They were mainly caused during the attempt to explant the component.In fact, they can't be seen in the picture of the component not explanted yet.- tibia component: no residual cement can be seen on the distal surface of the explanted component.It is something usual to be seen on explanted component, since the cement is a filler and not an adhesive.Degree of finishing of the distal surface of the component seems to be in compliance with the specification required.- tibia insert: no relevant considerations related to the event can be done from visual inspection of the explanted component.Conclusion: from visual inspection there is no evidence that may lead us relate the event to a faulty device.
Event or Problem Description
The patient came in complaining of stiffness.The surgeon determined the cement (non-medacta product) did not adhere to the implants.The surgeon revised the femur, insert and tibial tray.The surgery was completed successfully.

• Brand Name: GMK-PRIMARY FEMUR CEMENTED PS SIZE 4NARROW / RIGHT
• Common Device Name: KNEE FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6965216
• Report Number: 3005180920-2017-00597
• Device Sequence Number: 11048384
• Product Code: JWH
• UDI-Device Identifier: 07630030820991
• UDI-Public: 07630030820991
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K122232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/20/2017

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: 01/16/2021
• Device Catalogue Number: 02.07.2214R
• Device Lot Number: 156165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2017
• Initial Report FDA Received Date: 10/20/2017
• 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: 56 YR