MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 50/28; DOUBLE MOBILITY HC LINER Ø 50/28

Model Number 01.26.2850MHC

Device Problems Material Fragmentation (1261); Scratched Material (3020)

Patient Problem Joint Disorder (2373)

Event Date 03/27/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 31 march 2020 lot 164726: (b)(4) items manufactured and released on 12-oct-2016.Expiration date: 2021-09-29.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.Clinical evaluation performed by medical affairs director: partial revision (cup and head only) of primary cementless tha after 2.5 years.The pre-revision xrays show the cup in an unusual position.This may have been a choice at surgery because this patient had spinal fusion.We do not know if this cup position was chosen at the time of index surgery or if it is the result of cup migration.The choice of the dual mobility had been made, according to report, to compensate the particular requirements linked to the spinal surgery, but it is possible that some impingement between the cup and the femoral stem may have occurred nonetheless, particularly because of the position of the cup and the limited mobility of the patient's lumbar spine, which requires deep hip flexion for daily activities.No reason to suspect a faulty device.Preliminary investigation performed by r&d project manager: acetabular component extracted with signs of bone integration.Femoral head with scratches.Additional implants involved in the complaint, batch review performed on 31 march 2020: stem: quadra-h 01.12.34sn cementless, ha coated lat stem # 4, short neck (k093944) lot.Unknown.It is not possible to identify the specific lot number of the stem, so we are going to perform two batch review one ofr each lot number reported (170204 and 168413).Lot 170204: (b)(4) items manufactured and released on 21-apr-2017.Expiration date: 2022-04-09.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.Lot 168413: (b)(4) items manufactured and released on 01-mar-2017.Expiration date: 2022-02-21.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.Ball heads: mectacer 01.29.201 biolox delta ceramic ball head 12/14 ø 28 size s -3.5 (k112115) lot.Unknown it is not possible to identify the specific lot number of the ball head, so we are going to perform two batch review one for each lot number reported (163445 and 165964).Batch reviews performed on 06 april 2020 lot 163445: (b)(4) items manufactured and released on 04-oct-2016.Expiration date: 2021-09-21.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.Lot 165964: (b)(4) items manufactured and released on 16-jan-2017.Expiration date: 2022-01-03.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.

Event Description

The surgeon performed a bilateral primary thr in (b)(6) 2017.Right thr revised on (b)(6) 2019 following groin pain.Metallosis was present in the joint space.Left thr was revised on (b)(6) 2020 (more than 2 years and 5 months after the primary).The joint space didn't display metallosis as the other side had, but the explanted ceramic head showed scratching, indicating impingement with the femoral neck.X-rays showed lysis around the proximal femoral stem.It was not possible to identify the exact lot of stem (170204 or 168413) and ball head (163445 or 165964).

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 50/28
• Type of Device: DOUBLE MOBILITY HC LINER Ø 50/28
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; CH 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: 9989749
• MDR Text Key: 188734914
• Report Number: 3005180920-2020-00257
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030807282
• UDI-Public: 07630030807282
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K092265
• 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
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2021
• Device Model Number: 01.26.2850MHC
• Device Catalogue Number: 01.26.2850MHC
• Device Lot Number: 164726
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/12/2016
• 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 Age: 67 YR
• Patient Weight: 80