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

Model Number	01.32.158DH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 july 2022 lot 2104116: (b)(4) items manufactured and released on 19-july-2021.Expiration date: 2026-06-29.No anomalies found related to the problem.To date, 74 items of the same lot have been sold without any similar reported event during the period of review.Additional implanted components: batch review performed on 27 july 2022 stem: amistem p 01.18.413 amistem-p lat stem size 3 (k173794) lot.2106219: lot 2106219: (b)(4) items manufactured and released on 31-aug-2021.Expiration date: 2026-08-17.No anomalies found related to the problem.To date, 80 items of the same lot have been sold without any similar reported event during the period of review.Batch review performed on 27 july 2022 ball heads: mectacer 01.29.210 biolox delta ceramic ball head 12/14 ø 36 size l + 4 (k112115) lot.2115386: lot 2115386: (b)(4) items manufactured and released on 07-apr-2022.Expiration date: 2027-02-02.No anomalies found related to the problem.To date, 90 items of the same lot have been sold without any similar reported event during the period of review.Batch review performed on 27 july 2022 liner: mpact 01.32.3648hct flat pe hc liner ø36/f (k103721) lot.2116165: lot 2116165: (b)(4) items manufactured and released on 15-dec-2021.Expiration date: 2026-11-30.No anomalies found related to the problem.To date, 105 items of the same lot have been sold with another similar reported event during the period of review.
Event or Problem Description
At about 1 month after the primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised all implants.The surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø58 TWO-HOLES
• Common Device Name: HIP CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15156785
• Report Number: 3005180920-2022-00603
• Device Sequence Number: 20142344
• Product Code: LPH
• UDI-Device Identifier: 07630030810893
• UDI-Public: 07630030810893
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2022

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: 06/29/2026
• Device Model Number: 01.32.158DH
• Device Catalogue Number: 01.32.158DH
• Device Lot Number: 2104116
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2021
• 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