MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT DM CONVERTER; LINER: MPACT DM CONVERTER LINER G/DMF

Model Number	01.32.4452MC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 may 2025 lot 131964b: (b)(4) items manufactured and released on 23-feb-2018.Expiration date: 2023-02-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Additional devices involved: ball heads: mectacer 01.29.241a mectacer sleeve 12/14 size m (k131518) lot.180556 (b)(4) items manufactured and released on 24-05-2018.Expiration date: 2023-05-14.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Ball heads: mectacer 01.29.230h mectacer head biolox option 12/14 ø 28 (k131518) lot.186573 (b)(4) items manufactured and released on 30-nov-2018.Expiration date: 2023-10-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Liner: versafitcup dm 01.26.2852mhc double mobility hc liner ø 52/28 (k092265) lot.1810744 (b)(4) items manufactured and released on 04-feb-2019.Expiration date: 2024-01-21.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Stem: amistem h 01.18.144 ha coated lat stem size 4 (k093944) lot.112646 (b)(4) items manufactured and released on 13-oct-2011.Expiration date: 2016-08-31.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Root cause: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2015.Subsequently, the patient came in complaining of instability and the head and liner was revised on (b)(6) 2016.On (b)(6) 2019, 2 years and 9 months from the last revision, the patient came in reporting tightness and soreness due to the increased length and associated offset with the longer head from the previous revision.The revision surgery has been completed successfully.The ball head and liner have been revised.On (b)(6) 2025, the patient came in reporting thigh pain and the cause is unknown.The surgeon revised the stem, head and liner.The surgery was completed successfully.

• Brand Name: MPACT DM CONVERTER
• Common Device Name: LINER: MPACT DM CONVERTER LINER G/DMF
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 22060635
• Report Number: 3005180920-2025-00464
• Device Sequence Number: 7634823
• Product Code: MEH
• UDI-Device Identifier: 07630030812330
• UDI-Public: 07630030812330
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K131458
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• 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): 05/19/2025

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: 02/12/2023
• Device Model Number: 01.32.4452MC
• Device Lot Number: 131964B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2018
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 73 KG