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

Catalog Number	01.32.148MB
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 october 2019.Lot 185972: 20 items manufactured and released on 19-dec-2018.Expiration date: 2023-12-09.No anomalies found related to the problem.To date, 19 items of the same lot have been already sold without any other similar reported event.Additional items involved in the event, batch review performed on 09 october 2019.Stem: quadra-c 01.12.051 cemented, mirror polishing lat stem size 1 12/14 (k083558) lot.175306 lot 175306: 24 items manufactured and released on 11-oct-2017.Expiration date: 2022-09-28.No anomalies found related to the problem.To date, 14 items of the same lot have been already sold without any other similar reported event.Impact 01.33.101 mectaplug pe size 1 lot.1811301 (item not registered in usa).Lot 1811301: 209 items manufactured and released on 28-mar-2019.Expiration date: 2024-03-12.No anomalies found related to the problem.To date, 187 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.189636.Lot 189636: 240 items manufactured and released on 21-feb-2019.Expiration date: 2024-02-05.No anomalies found related to the problem.To date, 186 items of the same lot have been already sold with 3 other similar reported event.Liner: impact dm 01.26.2848mhc double mobility hc liner 28/dmd (k092265) lot.186322.Lot 186322: 168 items manufactured and released on 27-sep-2018.Expiration date: 2023-09-17.No anomalies found related to the problem.To date, 148 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
Revision following a suspicion of infection.All implants have been revised except the cup 3 weeks after primary.The surgery was completed successfully.

• 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: 9237118
• Report Number: 3005180920-2019-00906
• Device Sequence Number: 10795307
• Product Code: LPH
• UDI-Device Identifier: 07630030860959
• UDI-Public: 07630030860959
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 10/25/2019

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: 12/09/2023
• Device Catalogue Number: 01.32.148MB
• Device Lot Number: 185972
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 10/25/2019
• 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
• Patient Age: 80 YR