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

Model Number 01.32.148MB

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Joint Disorder (2373)

Event Date 06/10/2020

Event Type  Injury  

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 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
• Type of Device: HIP ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 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: 10238597
• MDR Text Key: 197796286
• Report Number: 3005180920-2020-00396
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07630030860959
• UDI-Public: 07630030860959
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143453
• 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: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 07/07/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/28/2018
• 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: 65 YR