MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø58 TWO-HOLES

Catalog Number	01.32.158DH
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in due to signs of infection and the pathogen is unknown.About 5 years and 4 months after the primary surgery, the surgeon removed all implants and placed an antibiotic spacer per the 2-stage infection protocol.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 24 november 2023.Lot 166611: (b)(4) items manufactured and released on 01-feb-2017.Expiration date: 2022-jan-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Additional items involved in the complaints, batch review performed on 24 november 2023: liner: mpact 01.32.3648hct flat pe hc liner ø36/f (k103721) lot.171741.Lot 171741: (b)(4) items manufactured and released on 27-sep-2017.Expiration date: 2022-sep-03.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Ball heads: mectacer 01.29.210 biolox delta ceramic ball head 12/14 ø 36 size l + 4 (k112115) lot.172272.Lot 172272: (b)(4) items manufactured and released on 31-jul-2017.Expiration date: 2022-sep-03.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Stem: masterloc 01.39.208 cementless ti coated lat stem size 8 (k151531) lot.171332.Lot 171332: (b)(4) items manufactured and released on 04-oct-2017.Expiration date: 2022-sep-24.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.
Additional Manufacturer Narrative
On (b)(6) 2024, permanent implants have been placed.The surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø58 TWO-HOLES
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18299556
• Report Number: 3005180920-2023-01034
• Device Sequence Number: 6936433
• Product Code: LPH
• UDI-Device Identifier: 07630030810893
• UDI-Public: 07630030810893
• 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: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2024

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: 01/22/2022
• Device Catalogue Number: 01.32.158DH
• Device Lot Number: 166611
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male