MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SHELL 56 TWO-HOLES; HIP CEMENTLESS SHELL

Model Number	01.32.156DH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24.06.2021: lot 2006111: (b)(4) items manufactured and released on 12-10-2020.Expiration date: 2025-10-01.No anomalies found related to the problem.To date, (b)(4) items of this same lot have been sold without other similar reported events.Additional devices involved: liner: mpact 01.32.3648hct flat pe hc liner ø36/f (k103721) lot.2009613: (b)(4) items manufactured and released on 28-10-2020.Expiration date: 2025-10-19.No anomalies found related to the problem.To date,(b)(4) items of this same lot have been sold without other similar reported events.Stem: amistem p 01.18.404 amistem-p std stem size 4 (k173794) lot.2005307: (b)(4) items manufactured and released on 01-09-2020.Expiration date: 2025-08-24.No anomalies found related to the problem.To date, (b)(4) items of this same lot have been sold without other similar reported events.Ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot.2007643: (b)(4) items manufactured and released on 18-11-2020.Expiration date: 2025-11-04.No anomalies found related to the problem.To date, (b)(4) items of this same lot have been sold without other similar reported events.
Event or Problem Description
3 months after the primary surgery the patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all implants and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: MPACT ACETABULAR SHELL 56 TWO-HOLES
• Common Device Name: HIP CEMENTLESS SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12133588
• Report Number: 3005180920-2021-00560
• Device Sequence Number: 3704696
• Product Code: LPH
• UDI-Device Identifier: 07630030810855
• UDI-Public: 07630030810855
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2021

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: 10/01/2025
• Device Model Number: 01.32.156DH
• Device Catalogue Number: 01.32.156DH
• Device Lot Number: 2006111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 07/08/2021
• 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