MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT FLAT PE HC LINER Ø32/D; HIP SHELL LINER

Model Number	01.32.3241HCT
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30-may-2023: lot 2118345: (b)(4) items manufactured and released on 31-jan-2022.Expiration date: 2027-01-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Additional device involved: batch review performed on 30-may-2023: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115) lot 2201966: 180 items manufactured and released on 04-may-2022.Expiration date: 2027-04-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of the review.
Event or Problem Description
At about 2 months after the primary surgery, the patient came in reporting pain due to a dislocation of the head from the liner and the cause is unknown.The surgeon revised successfully the liner and the head.

• Brand Name: MPACT FLAT PE HC LINER Ø32/D
• Common Device Name: HIP SHELL 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: 17190145
• Report Number: 3005180920-2023-00441
• Device Sequence Number: 12597180
• Product Code: LPH
• UDI-Device Identifier: 07630030811876
• UDI-Public: 07630030811876
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2023

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: 01.32.3241HCT
• Device Catalogue Number: 01.32.3241HCT
• Device Lot Number: 2118345
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2022
• 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