MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT HOODED PE HC LINER Ø36/E; HIP ACETABULAR LINER

Model Number	01.32.3644HCAT
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	12/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022.Lot 1900229: 50 items manufactured and released on 28-mar-2019.Expiration date: 2024-03-05.No anomalies found related to the problem.To date, 48 items of the same lot have been sold with no similar reported case during the period of review.Additional component involved: ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot 2206351: 198 items manufactured and released on 31-may-2022.Expiration date: 2027-05-16.No anomalies found related to the problem.To date, 174 items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
At about 1 month and 2 weeks after the primary surgery, the patient came in due to signs of infection and the pathogen is unknown.The surgeon performed a washout and revised successfully the head and liner.

• Brand Name: LINER: MPACT HOODED PE HC LINER Ø36/E
• Common Device Name: HIP ACETABULAR LINER
• 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: 16004172
• Report Number: 3005180920-2022-00976
• Device Sequence Number: 20275498
• Product Code: LPH
• UDI-Device Identifier: 07630030812101
• UDI-Public: 07630030812101
• 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): 12/19/2022

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: 03/05/2024
• Device Model Number: 01.32.3644HCAT
• Device Catalogue Number: 01.32.3644HCAT
• Device Lot Number: 1900229
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2019
• 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 Age: 66 YR
• Patient Sex: Male