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

Model Number	01.32.3248HCT
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 october 2020: lot 1906067: (b)(4) items manufactured and released on 24-jul-2019.Expiration date: 2024-07-07.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.Other devices involved in the event: ball heads: mectacer 01.29.204 biolox delta ceramic ball head 12/14 ø 32 size s -4 lot.1907342 (k112115).Batch review performed on 27 october 2020: lot 1907342: (b)(4) items manufactured and released on 08-jan-2020.Expiration date: 2024-12-15.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.Cup: mpact 01.32.156dh acetabular shell ø56 two-holes lot.1907402 (k132879).Batch review performed on 27 october 2020: lot 1907402: (b)(4) items manufactured and released on 08-nov-2019.Expiration date: 2024-10-28.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
While the patient was in post-op recovery, the patient head dislocated from the liner.The cause for the dislocation was an anteverted cup.The surgeon revised the patient's cup, head, and liner the same day of primary surgery.The surgery was completed successfully.

• Brand Name: LINER: MPACT FLAT PE HC LINER 32/F
• Common Device Name: FLAT PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10843088
• Report Number: 3005180920-2020-00812
• Device Sequence Number: 11490117
• Product Code: LPH
• UDI-Device Identifier: 07630030811951
• UDI-Public: 07630030811951
• Combination Product (Y/N): Y
• 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: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/16/2020

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: 07/07/2024
• Device Model Number: 01.32.3248HCT
• Device Catalogue Number: 01.32.3248HCT
• Device Lot Number: 1906067
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 11/16/2020
• 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