MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT DOUBLE MOBILITY ACETABULAR SHELL 52; HIP CEMENTLESS SHELL

Model Number	01.32.152MB
Health Effect - Clinical Code	Unequal Limb Length (4534)
Date of Event	07/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 august 2021: lot 1909301: (b)(4) items manufactured and released on 09-mar-2020.Expiration date: 2025-02-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional devices involved.Batch reviews performed on 03 august 2021: liner: versafitcup dm 01.26.2852mhc double mobility hc liner 28/dmf (k092265) lot 1909378: (b)(4) items manufactured and released on 22-jan-2020.Expiration date: 2024-12-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Stem: masterloc 01.39.406 cementless ti coated lat plus stem size 6 (k173267) lot 182236: (b)(4) items manufactured and released on 04-jul-2018.Expiration date: 2023-06-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Ball heads: mectacer 01.29.201 biolox delta ceramic ball head 12/14 ø 28 size s -3.5 (k112115) lot 1903846: (b)(4) items manufactured and released on 24-jul-2019.Expiration date: 2024-07-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been without another similar reported event.
Event or Problem Description
The patient came in reporting pain due to a leg length discrepancy and an anteverted cup (for unknown reasons).1 year and 1 month after the primary surgery, the surgeon revised the stem, head, cup and liner and replaced them with competitor components.The surgery was completed successfully.

• Brand Name: MPACT DOUBLE MOBILITY ACETABULAR SHELL 52
• Common Device Name: HIP CEMENTLESS SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12364560
• Report Number: 3005180920-2021-00685
• Device Sequence Number: 3974196
• Product Code: LPH
• UDI-Device Identifier: 07630030860973
• UDI-Public: 07630030860973
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 08/25/2021

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: 02/25/2025
• Device Model Number: 01.32.152MB
• Device Catalogue Number: 01.32.152MB
• Device Lot Number: 1909301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 08/25/2021
• 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