MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø60 TWO-HOLES; HIP ACETABULAR CUP CEMENTLESS

Model Number	01.32.160DH
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16-aug-2022.Lot 2111424: (b)(4) items manufactured and released on 22-nov-2021.Expiration date: 2026-11-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Additional components involved: liner: mpact 01.32.4052hct flat pe hc liner ø40/g (k122641) lot 2116168: (b)(4) items manufactured and released on 28-dec-2021.Expiration date: 2026-12-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Stem: sms solid 01.36.151 sms collared solid stem std size 11 (k203041) lot 2103767: (b)(4) items manufactured and released on 02-aug-2021.Expiration date: 2026-07-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Ball heads: mectacer 01.29.214 biolox delta ceramic ball head 12/14 ø 40 size l + 4 (k112115) lot 2111117: (b)(4) items manufactured and released on 29-nov-2021.Expiration date: 2026-11-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Screws: mpact 01.43.0025 cancellous bone screw ø 6,5 l 25 (k200391) lot 2109277: (b)(4) items manufactured and released on 10-nov-2021.Expiration date: 2026-10-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
At about 2 months and 3 weeks after the primary surgery, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all implants, and implanted an antibiotic spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
Permanent hardware was implanted in this patient on (b)(6) 2023.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø60 TWO-HOLES
• Common Device Name: HIP ACETABULAR CUP CEMENTLESS
• 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: 15368483
• Report Number: 3005180920-2022-00676
• Device Sequence Number: 6277789
• Product Code: LPH
• UDI-Device Identifier: 07630030810930
• UDI-Public: 07630030810930
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2023

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 Model Number: 01.32.160DH
• Device Catalogue Number: 01.32.160DH
• Device Lot Number: 2111424
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2021
• 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