MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø48 TWO-HOLES

Model Number	01.32.148DH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 april 2020: lot 188865: (b)(4) items manufactured and released on 22-feb-2019.Expiration date: 2024-02-13.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.Other devices involved in the event: liner: mpact 01.32.3239hct flat pe hc liner ø32/c lot.179359 (k103721).Batch review performed on 07 april 2020: lot 179359: (b)(4) items manufactured and released on 17-apr-2018.Expiration date: 2023-04-04.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.Stem: amistem collared 01.18.230 stem collared ha coated std stem #0 lot.176018 (k121011).Batch review performed on 07 april 2020: lot 176018: (b)(4) items manufactured and released on 31-jan-2018.Expiration date: 2023-01-21.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 01.29.204 biolox delta ceramic ball head 12/14 ø 32 size s -4 (k112115).Batch review performed on 07 april 2020: lot 189638: (b)(4) items manufactured and released on 19-feb-2019.Expiration date: 2024-02-05.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 due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and removed all implants and implanted an antibiotic spacer almost 11 months after primary.The surgery was complete successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø48 TWO-HOLES
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10009077
• Report Number: 3005180920-2020-00267
• Device Sequence Number: 19557610
• Product Code: LPH
• UDI-Device Identifier: 07630030810732
• UDI-Public: 07630030810732
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/29/2020

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: No Information
• Device Expiration Date: 02/13/2024
• Device Model Number: 01.32.148DH
• Device Catalogue Number: 01.32.148DH
• Device Lot Number: 188865
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 04/29/2020
• 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: 60 YR