MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø56

Catalog Number	01.32.156MB
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the second revision surgery underwent by this patient.The patient had a primary hip on (b)(6) 2017.On (b)(6) 2017 the patient had a poly and head revised due to infection.Then, the patient was revised again for infection on (b)(6) 2017.Batch reviews performed on 21 july 2017.Lot 165665: (b)(4) items manufactured and released on 20 december 2016.Expiration date: 2021-12-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Cocr ball head 12/14 ø 28 size m 0, code 01.25.012, lot.163206 (k072857) lot 163206: (b)(4) items manufactured and released on 02 august 2016.Expiration date: 2021-07-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Mpact dm double mobility hc liner 28/dmh, code 01.26.2856mhc, lot.164475 (k092265) (b)(4) items manufactured and released on 13 october 2016.Expiration date: 2021-09-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Amistem c, cemented stem size 3 std, code 01.18.153, lot.165834 (k103189) (b)(4) items manufactured and released on 13 december 2016.Expiration date: 2021-12-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient was revised for infection.The surgeon revised all medacta components and implanted a spacer.The surgery was completed successfully.X-rays and explants are not available.

• Brand Name: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø56
• Common Device Name: DOUBLE MOBILITY ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6731941
• Report Number: 3005180920-2017-00400
• Device Sequence Number: 16454613
• Product Code: LPH
• UDI-Device Identifier: 07630030860997
• UDI-Public: 07630030860997
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/21/2017

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: 12/08/2021
• Device Catalogue Number: 01.32.156MB
• Device Lot Number: 165665
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2017
• Initial Report FDA Received Date: 07/21/2017
• 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: 69 YR