MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMH; DOUBLE MOBILITY HIP LINER

Model Number	01.26.2856MHC
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	12/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 january 2023: lot 2104156: (b)(4) items manufactured and released on 15-jun-2021.Expiration date: 2026-06-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Additional items involved in the event, batch review performed on 03 january 2023: ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 (k112115) lot.2203050 lot 2203050: (b)(4) items manufactured and released on 18-may-2022.Expiration date: 2027-04-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Stem: quadra-p 01.12.124 quadra-p std stem size 4 (k181254) lot.2117662 lot 2117662: (b)(4) items manufactured and released on 11-may-2022.Expiration date: 2027-04-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Cup: mpact 01.32.156mb double mobility acetabular shell ø56 (k143453) lot.2111694 lot 2111694: (b)(4) items manufactured and released on 25-mar-2022.Expiration date: 2027-03-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.
Event or Problem Description
The patient came in due to signs of a staphylococcus infection and the cause is unknown.At about 2 months post primary the surgeon performed a washout and revised all implants.The surgery was completed successfully.

• Brand Name: LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMH
• Common Device Name: DOUBLE MOBILITY HIP LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 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: 16156630
• Report Number: 3005180920-2023-00003
• Device Sequence Number: 7396429
• Product Code: MEH
• UDI-Device Identifier: 07630030807411
• UDI-Public: 07630030807411
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2023

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: 06/01/2026
• Device Model Number: 01.26.2856MHC
• Device Catalogue Number: 01.26.2856MHC
• Device Lot Number: 2104156
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2021
• 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 Sex: Male