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

Model Number	01.32.3244HCT
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 may 2020 lot 1905498: (b)(4) items manufactured and released on 27-jun-2019.Expiration date: 2024-06-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional items involved in the event, batch review performed on 15 may 2020: ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 32 size m 0 (k112115) lot.180535.Lot 180535: (b)(4) items manufactured and released on 13-jul-2018.Expiration date: 2023-07-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
Immediately following the primary hip surgery and while the patient was in post-op, the head dislocated from the liner.The surgeon revised the size 4 stem to a size 6 stem and revised the 32mm biolox head m with a 32mm biolox head m the same day of primary.The surgery was completed successfully.

• Brand Name: LINER: MPACT FLAT PE HC LINER Ø32/E
• Common Device Name: FLAT PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; CH 6874
• MDR Report Key: 10136933
• Report Number: 3005180920-2020-00313
• Device Sequence Number: 2319039
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2020

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: 06/15/2024
• Device Model Number: 01.32.3244HCT
• Device Catalogue Number: 01.32.3244HCT
• Device Lot Number: 1905498
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 06/10/2020
• 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: 65 YR