MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER Ø36/F; HIP LINER

Model Number	01.32.3648HCT
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	06/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 july 2023: 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, (b)(4) items of the same lot have been sold with other 2 similar reported event in the period of review.Additional devices involved, batch review performed on 04 july 2023: ball heads: mectacer 01.29.211 biolox delta ceramic ball head 12/14 ø 36 size xl +8 (k112115) lot 1907363 lot 1907363: (b)(4) items manufactured and released on 20-nov-2019.Expiration date: 2024-11-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event in the period of review.Stem: sms solid 01.36.045 sms solid stem std size 5 (k181693) lot.2114510 lot 2114510: (b)(4) items manufactured and released on 09-mar-2022.Expiration date: 2027-02-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Cup: mpact 3d metal 01.38.056dh acetabular shell ø56 two-hole (k171966) lot.2119570.Lot 2119570: (b)(4) items manufactured and released on 31-jan-2022.Expiration date: 2027-01-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2022.On (b)(6) 2022, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the head and liner (emdr 2022-00792).The surgery was completed successfully.Presently, on (b)(6) 2023, 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: LINER: MPACT FLAT PE HC LINER Ø36/F
• Common Device Name: HIP 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17316329
• Report Number: 3005180920-2023-00516
• Device Sequence Number: 20362367
• Product Code: LPH
• UDI-Device Identifier: 07630030812132
• UDI-Public: 07630030812132
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 07/13/2023

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: 01.32.3648HCT
• Device Catalogue Number: 01.32.3648HCT
• Device Lot Number: 2116165
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2021
• 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