MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES; HIP ACETABULAR CUP

Catalog Number	01.32.154DH
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	04/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23-apr-2024.Lot 2303387: (b)(4) items manufactured and released on 04-jul-2023.Expiration date: 2028-06-18.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 components revised: ball heads: mectacer 01.29.210 biolox delta ceramic ball head 12/14 ø 36 size l + 4 (k112115) lot 2317274: (b)(4) items manufactured and released on 13-jul-2023.Expiration date: 2028-06-24.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.Liner: mpact 01.32.3644hct flat pe hc liner ø36/e (k103721) lot 2316736: (b)(4) items manufactured and released on 08-aug-2023.Expiration date: 2028-07-23.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.Stem: sms solid 01.36.048 sms solid stem std size 8 (k1816939 lot 2219011: (b)(4) items manufactured and released on 17-jan-2023.Expiration date: 2027-12-27.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
At about 4 months after primary, 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.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES
• Common Device Name: HIP ACETABULAR CUP
• 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: 19328373
• Report Number: 3005180920-2024-00306
• Device Sequence Number: 19585595
• Product Code: LPH
• UDI-Device Identifier: 07630030810824
• UDI-Public: 07630030810824
• 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: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2024

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 Catalogue Number: 01.32.154DH
• Device Lot Number: 2303387
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/04/2023
• 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