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

Model Number	01.32.3244HCT
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023 lot 179361: (b)(4) manufactured and released on 25-apr-2018.Expiration date: 2023-04-13.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event during the period of review.Additional component involved: ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115) lot.178802: (b)(4) manufactured and released on 23-apr-2018.Expiration date: 2023-04-11.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Cup: mpact 01.32.152mh acetabular shell ø52 multi-hole (k132879) lot.180088: (b)(4) manufactured and released on 17-may-2018.Expiration date: 2023-05-14.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
At about 4 years 7 months after the primary, the patient came in reporting pain due to joint luxation and the cause is unknown.The surgeon revised the head, liner and the cup that was originally positioned too anteverted.The surgery was completed successfully.

• Brand Name: LINER: MPACT FLAT PE HC LINER Ø32/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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17030474
• Report Number: 3005180920-2023-00381
• Device Sequence Number: 17757223
• Product Code: LPH
• UDI-Device Identifier: 07630030811913
• UDI-Public: 07630030811913
• 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: 2018
• 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): 05/31/2023

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 Expiration Date: 04/13/2023
• Device Model Number: 01.32.3244HCT
• Device Catalogue Number: 01.32.3244HCT
• Device Lot Number: 179361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2018
• 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: 69 YR
• Patient Sex: Female