MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT 01.32.150SH ACETABULAR SHELL 50 NO-HOLE; HIP ACETABULAR SHELL

Model Number	01.32.150SH
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	06/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06.07.2021: lot 2010308: (b)(4) items manufactured and released on 11-jan-2021.Expiration date: 2025-12-22 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold.No other similar events have been reported on this lot.Additional devices involved: mectacer 01.29.409 ceramic liner ø 32 / d (device not distributed in us) lot.2009421: (b)(4) items manufactured and released on 20-jan-2021.Expiration date: 2026-01-11 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold.No other similar events have been reported on this lot.Mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115) lot.2007632: (b)(4) items manufactured and released on 24-nov-2020.Expiration date: 2025-11-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold.No other similar events have been reported on this lot.Amistem p 01.18.414 amistem-p lat stem #4 lot (k173794) 1910440: (b)(4) items manufactured and released on 09-apr-2020.Expiration date: 2025-03-31 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold.No other similar events have been reported on this lot.
Event or Problem Description
Revision surgery performed 1 month after the primary due to soft tissue healing issues (obese patient).The surgeon revised the liner and the femoral head.The swabs were sent to a laboratory for infection, in order to check if any bacteria are present(results will be available later).It is unknown if the device will be available.

• Brand Name: MPACT 01.32.150SH ACETABULAR SHELL 50 NO-HOLE
• Common Device Name: HIP ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12216034
• Report Number: 3005180920-2021-00596
• Device Sequence Number: 19960232
• Product Code: LPH
• UDI-Device Identifier: 07630030810787
• UDI-Public: 07630030810787
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 07/23/2021

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: 12/22/2025
• Device Model Number: 01.32.150SH
• Device Catalogue Number: 01.32.150SH
• Device Lot Number: 2010308
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/23/2021
• 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