MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø50; UNCEMENTED HIP SHELL

Catalog Number	01.32.150MB
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10-sep-2019: lot 183907: (b)(4) items manufactured and released on 10-sep-2018.Expiration date: 29/08/2023.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.Additional device involved: batch reviews performed on 10-sep-2019: liner: mpact dm 01.26.2850mhc double mobility hc liner 28/dme (k092265) lot 184724: (b)(4) items manufactured and released on 11-sep-2018.Expiration date: 19.08.2023.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with 1 other similar reported event stem: amistem p 01.18.412 amistem-p lat stem size 2 (k173794); lot 180742: (b)(4) items manufactured and released on 27-jun-2018.Expiration date: 12.06.2023.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 01.29.203 biolox delta ceramic ball head 12/14 ø 28 size l +3.5 (k112115); lot 176812: (b)(4) items manufactured and released on 29-mar-2018.Expiration date: 13.03.2023.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 came in complaining of pain 7 months after primary, the cause of the pain is unknown.The surgeon removed all medacta hardware and implanted a competitor's products into the patient.

• Brand Name: CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø50
• Common Device Name: UNCEMENTED HIP SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8987628
• Report Number: 3005180920-2019-00766
• Device Sequence Number: 16966126
• Product Code: LPH
• UDI-Device Identifier: 07630030860966
• UDI-Public: 07630030860966
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2019

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: 08/29/2023
• Device Catalogue Number: 01.32.150MB
• Device Lot Number: 183907
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 09/11/2019
• 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