MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3; HIP CEMENTLESS STEM

Model Number 01.12.033

Device Problems Material Deformation (2976); Naturally Worn (2988)

Patient Problem Granuloma (1876)

Event Date 09/17/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed by medacta regulatory affairs department on 29 september 2020: lot 061366: (b)(4) items manufactured and released on 18-oct-2006.Expiration date: 2011-09-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with 1 similar reported event since 2016.Clinical evaluation performed by medical affairs director: revision of primary cementless tha after 14 years.The original acetabular insert was standard polyethylene; it is accepted in literature that this material may undergo some wear during the years.No information on patient age or activity level is available.In spite of the low-quality images, some osteolytic reactions, that may be due to polyethylene wear, are visible in the femoral periprosthetic bone.Quantitative analysis of the wear seems to be hardly feasible due to the treatment that the insert underwent during removal procedure and subsequent cleaning.No radiographic history of the case is available.At this stage, we do not see reasons to suspect a faulty device.Visual inspection performed by r&d project manager: from the received piece it was evident a big deformation of the liner due to the post removal surgery sterilization at 134°, as confirmed by the branch.Due to the high deformation of the liner, it is not possible to determine the real deformation value due to a possible wear; anyway, as the material is a standard polyethylene, it is possible that a deformation due to wear occurred.For these reasons, there are no motivations to suspect a failure of the device.Other devices involved in the event: liner: cc e cc light 01.26.3244stt flat pe liner ø 32 / e lot.061137 (k103352).Batch review performed by medacta regulatory affairs department on 29 september 2020: lot 061137: (b)(4) items manufactured and released on 09-oct-2006.Expiration date: 2011-07-31.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 since 2016.

Event Description

Revision surgery performed after 13 years and 10 months from the primary surgery due to stem mobilization.The stem and insert were revised.During the revision surgery, it was noticed that the liner seem to be worn( not centrally).The surgeon informed that in the histology it was found some granulation tissue with polyethylene wear inside and that in the preoperative x-rays you can see that the head is not central anymore in the cup.After the revision surgery, the liner was sterilized at 134°c end arrived to medacta deformed.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3
• Type of Device: HIP CEMENTLESS STEM
• 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, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 10690346
• MDR Text Key: 211709644
• Report Number: 3005180920-2020-00709
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802157
• UDI-Public: 07630030802157
• Combination Product (y/n): Y
• Reporter Country Code: SZ
• PMA/PMN Number: K082792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2011
• Device Model Number: 01.12.033
• Device Catalogue Number: 01.12.033
• Device Lot Number: 061366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/16/2020
• Supplement Dates Manufacturer Received: 09/17/2020
• Supplement Dates FDA Received: 12/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 73