MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48

Catalog Number	01.32.148MB
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 september 2019 lot 166635: (b)(4) items manufactured and released on 15-feb-2017.Expiration date: 2022-02-07.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 implants involved in the event, batch review performed on 05 september 2019 stem: amistem h 01.18.141 ha coated lat stem size 1 (k093944) lot.161434 lot 161434: (b)(4) items manufactured and released on 16-jun-2016.Expiration date: 2021-05-26.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.Liner: versafitcup dm 01.26.2848 mhc double mobility hc liner ø 48/28 (k092265) lot.171727 lot 171727: (b)(4) items manufactured and released on 26-jul-2017.Expiration date: 2022-07-09.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 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 (k112115) lot.171403.Lot 171403: (b)(4) items manufactured and released on 25-jul-2017.Expiration date: 2022-07-18.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.The cause of the pain is unknown.The surgeon did not provide any additional details.The revision surgery will take place on (b)(6) 2019.More details to follow once the revision surgery has been completed.
Additional Manufacturer Narrative
The patient has been complaining of pain and the cause of the pain is unknown.Numerous labs have been taken and the surgeon, about 2 years after primary decided to explant all hardware and implant an antibiotic spacer.The surgery was completed successfully.When the agent was asked if this was an infection, she replied that the surgeon is not sure what the issue is but decided to remove all hardware and take labs.

• Brand Name: CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48
• Common Device Name: DOUBLE MOBILITY ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9122616
• Report Number: 3005180920-2019-00809
• Device Sequence Number: 2657405
• Product Code: LPH
• UDI-Device Identifier: 07630030860959
• UDI-Public: 07630030860959
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2019

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: 02/07/2022
• Device Catalogue Number: 01.32.148MB
• Device Lot Number: 166635
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 08/28/2019; 08/28/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 10/31/2019; 12/06/2019
• 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