MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL 48; HIP ACETABULAR SHELL

Model Number	01.32.148MB
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	06/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 june 2020: lot 183906: (b)(4) items manufactured and released on 28-aug-2018.Expiration date: 2023-08-19.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.Additiona devices involved: batch reviews performed on 16 june 2020: liner: mpact dm 01.26.2848mhc double mobility hc liner 28/dmd (k092265) lot 1901454: (b)(4) items manufactured and released on 23-may-2019.Expiration date: 2024-05-12.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 1810791: (b)(4) items manufactured and released on 01-mar-2019.Expiration date: 2024-02-19.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 or Problem Description
The patient had a primary hip surgery on (b)(6) 2019.Subsequently, the patient came in reporting pain due to a subsided stem.On (b)(6) 2019, the surgeon revised the stem, head and liner.Presently (1 year after previous surgery), the patient came in reporting pain and the cause of pain is unknown.The surgeon revised the medacta cup and liner with another company's product and revised the medacta head with a medacta head the surgery was completed successfully.

• Brand Name: CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL 48
• Common Device Name: HIP ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10238597
• Report Number: 3005180920-2020-00396
• Device Sequence Number: 16346730
• Product Code: LPH
• UDI-Device Identifier: 07630030860959
• UDI-Public: 07630030860959
• 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: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/19/2023
• Device Model Number: 01.32.148MB
• Device Catalogue Number: 01.32.148MB
• Device Lot Number: 183906
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 07/07/2020
• 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
• Patient Age: 65 YR