MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT 01.32.148DH ACETABULAR SHELL Ø48 TWO-HOLES; HIP ACETABULAR CUP

Model Number	01.32.148DH
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.About 20 days after the primary surgery, the surgeon performed a washout and revised all components and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 10 october 2022 on lot 2117774: (b)(4) items manufactured and released on 29-mar-2022.Expiration date: 2027-mar-17.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 involved implants batch review performed on 10 october 2022 on liner: mpact 01.32.3239hct flat pe hc liner ø32/c (k103721) lot 2118342: (b)(4) items manufactured and released on 10-mar-2022.Expiration date: 2027-jan-16.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.Batch review performed on 10 october 2022 on stem: sms solid 01.36.162 sms collared solid stem lat size 2 (k203041) lot 2102620: (b)(4) items manufactured and released on 19-jul-2021.Expiration date: 2026-jun-21.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.Batch review performed on 10 october 2022 on ball heads: mectacer 01.29.204 biolox delta ceramic ball head 12/14 ø 32 size s -4 (k112115) lot.2119452: (b)(4) items manufactured and released on 30-mar-2022.Expiration date: 2027-mar-21.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.

• Brand Name: CUP: MPACT 01.32.148DH ACETABULAR SHELL Ø48 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15692444
• Report Number: 3005180920-2022-00798
• Device Sequence Number: 7337932
• 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: 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
• Report Date (Section B): 10/28/2022

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 Model Number: 01.32.148DH
• Device Catalogue Number: 01.32.148DH
• Device Lot Number: 2117774
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2022
• 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: Female