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

Catalog Number	01.32.3644HCAT
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	03/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 april 2024.Lot 2314989: (b)(4) items manufactured and released on 08-aug-2023.Expiration date: 2028-07-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Additional involved implants: batch review performed on 24-apr-2024 on ball heads: mectacer 01.29.208 mectacer head biolox delta dia.36 12/14-s (k112115) lot.2340140.Lot 2340140: (b)(4) items manufactured and released on 25-oct-2023.Expiration date: 2028-10-08.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 24 april 2024 on mpact 01.32.152dh acetabular shell ø52 two-holes (k132879) lot.2336164.Lot 2336164: (b)(4) items manufactured and released on 13-dec-2023.Expiration date: 2028-11-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Batch review performed on 24 april 2024 on stem: amistem p 01.18.402 amistem-p lat stem size 7 (k173794) lot.2218935.Lot 2218935: (b)(4) items manufactured and released on 28-nov-2022.Expiration date: 2027-11-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
Revision surgery due to joint luxation, few days after the primary surgery and close reduction.The hip was unstable also during revision surgery and led to surgeon decision to revise all components.

• Brand Name: LINER: MPACT HOODED PE HC LINER Ø36/E
• Common Device Name: HIP POLYETHYLENE HIGH CROSS 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: 19173866
• Report Number: 3005180920-2024-00264
• Device Sequence Number: 7455777
• Product Code: LPH
• UDI-Device Identifier: 07630030812101
• UDI-Public: 07630030812101
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 04/24/2024

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: 01.32.3644HCAT
• Device Lot Number: 2314989
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2023
• 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 Sex: Unknown