MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER 32/C

Model Number	01.32.3239HCT
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 25 january 2021: lot 1907426: (b)(4) items manufactured and released on 17-sep-2019.Expiration date: 2024-09-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events.Additional item involved in the event, batch review performed by medacta regulatory affairs department on 25 january 2021: ball heads: mectacer 01.29.206 biolox delta ceramic ball head 12/14 ø 32 size l +4 (k112115) lot.1907349.Lot 1907349: (b)(4) items manufactured and released on 8-jan-2020.Expiration date: 2024-12-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events.
Event or Problem Description
The patient came in after 4 months from the primary surgery reporting instability and the cause of the instability is unknown.The surgeon revised the head and liner (the same size) and the surgery was completed successfully.There was no implant mobilization.

• Brand Name: LINER: MPACT FLAT PE HC LINER 32/C
• Common Device Name: FLAT PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11320657
• Report Number: 3005180920-2021-00107
• Device Sequence Number: 19868538
• Product Code: LPH
• UDI-Device Identifier: 07630030811845
• UDI-Public: 07630030811845
• 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: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/12/2021

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: 09/04/2024
• Device Model Number: 01.32.3239HCT
• Device Catalogue Number: 01.32.3239HCT
• Device Lot Number: 1907426
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR