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

Catalog Number	01.32.3644HCT
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During the hip surgery, the trial reduction was performed using a cup 52mm, liner 36mm, and head 36mm, sleeve s.Since there was no dislocation tendency, the implants of the same sizes were inserted in the same positions as trials.However, it was noticed that the implant tended to dislocate.In addition, cup fixation was poor.The surgery was successfully completed using a cup 54 mm, liner 36 mm and head, sleeve m.
Additional Manufacturer Narrative
Batch review performed on 28-aug-2023 lot 2247621: 100 items manufactured and released on 16-feb-2023.Expiration date: 2028-01-31.No anomalies found related to the problem.To date, 68 items of the same lot have been sold with no similar reported event during the period of review.Visual inspection performed by r&d project manager: the cup and the sleeve were analyzed.From the received parts, no particular signs of evidence of device failure were noticed: the shell showed some tissue in the pyramidal net and an internal groove due to damages occurred during the removal (probably with the screw), while the sleeve did not present particular signs.Additional items involved in the event, batch review performed on 28-aug-2023 ball heads: mectacer 01.29.232h head biolox option ø 36 (k131518) lot.2248508 lot 2248508: 20 items manufactured and released on 17-jan-2023.Expiration date: 2027-12-18.No anomalies found related to the problem.To date, 9 items of the same lot have been sold with no similar reported event during the period of review.Cup: mpact 3d metal 01.38.352mh acetabular shell ø52 multi-hole thin (k202568) lot.2007121 lot 2007121: 52 items manufactured and released on 30-ott-2020.Expiration date: 2025-10-21.No anomalies found related to the problem.To date, 20 items of the same lot have been sold with no similar reported event during the period of review.Ball heads: mectacer 01.29.240a sleeve size s (k131518) lot.176412b lot 176412b: 3 items manufactured and released on 5-apr-2023.Expiration date: 2028-03-18.No anomalies found related to the problem.To date, 2 items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: LINER: MPACT FLAT PE HC LINER Ø36/E
• Common Device Name: FLAT PE 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: 17779522
• Report Number: 3005180920-2023-00719
• Device Sequence Number: 6634516
• Product Code: LPH
• UDI-Device Identifier: 07630030812118
• UDI-Public: 07630030812118
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 09/20/2023

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 Catalogue Number: 01.32.3644HCT
• Device Lot Number: 2247621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2023
• 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 Age: 83 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian