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

Catalog Number	01.32.3241HCT
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19-07-2019: lot 182609: (b)(4) items manufactured and released on 02-jul-2018.Expiration date: 2023-06-18.No anomalies found related to the problem.To date, 89 items of the same lot have been already sold without any other similar reported event.Additional implant: ball heads: mectacer 01.29.204 biolox delta ceramic ball head 12/14 ø 32 size s -4 lot.183340 (k112115).Batch review performed on 19-07-2019: lot 183340: (b)(4) items manufactured and released on 10-sept-2018.Expiration date: 2023-08-26.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
The patient came in complaining of pain due to a dislocation of the head from the liner almost 4 months after primary.The surgeon revised the 32mm biolox head s with a 32mm biolox head l.The surgery was completed successfully.We were informed about the event on (b)(4), the revision surgery was performed on (b)(6).

• Brand Name: MPACT FLAT PE HC LINER Ø32/D
• Common Device Name: HIP PE LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8878377
• Report Number: 3005180920-2019-00664
• Device Sequence Number: 2048633
• Product Code: LPH
• UDI-Device Identifier: 07630030811876
• UDI-Public: 07630030811876
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2019

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: 06/18/2023
• Device Catalogue Number: 01.32.3241HCT
• Device Lot Number: 182609
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 08/09/2019
• 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