MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT 01.32.2837HCT FLAT PE HC LINER Ø28/B; HIP LINER FLAT

Model Number	01.32.2837HCT
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	10/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 october 2021.Lot 188502: (b)(4).Expiration date: 2023-nov-11.No anomalies found related to the problem.(b)(4).Other devices involved: batch review performed on 19 october 2021.Mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 (k112115) lot 2006678: (b)(4).Expiration date: 2025-sep-24.No anomalies found related to the problem.(b)(4).
Event or Problem Description
The patient came in reporting pain due to a dislocation of the head from the liner and the cause of the dislocation is unknown.The surgeon revised the head and liner 2 months after the primary surgery, and the surgery was completed successfully.

• Brand Name: MPACT 01.32.2837HCT FLAT PE HC LINER Ø28/B
• Common Device Name: HIP LINER FLAT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 12787117
• Report Number: 3005180920-2021-00877
• Device Sequence Number: 14454217
• Product Code: LPH
• UDI-Device Identifier: 07630030811531
• UDI-Public: 07630030811531
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 11/10/2021

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: 11/11/2023
• Device Model Number: 01.32.2837HCT
• Device Catalogue Number: 01.32.2837HCT
• Device Lot Number: 188502
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2018
• 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: Other
• Patient Sex: Female