MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT HCAT HOODED PE HC LINER 32/D; HIP LINER HOODED

Model Number	01.32.3241HCAT
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 june 2020: lot 163260: (b)(4) items manufactured and released on 07-sep-2016.Expiration date: 2021-08-28.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.Other device involved in the event: ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 lot.165968 (k112115).Batch review performed on 12june 2020: lot 165968: (b)(4) items manufactured and released on 11-jan-2017.Expiration date: 2021-12-20.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 reporting pain due to a dislocation of the head from the liner.The surgeon revised the medacta head with a medacta head and revised the medacta cup and liner with another company's cup and liner 2 years and 9 months after primary.The surgery was completed successfully.A posterior approach was used in the primary surgery.

• Brand Name: LINER: MPACT HCAT HOODED PE HC LINER 32/D
• Common Device Name: HIP LINER HOODED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10232763
• Report Number: 3005180920-2020-00390
• Device Sequence Number: 18975981
• Product Code: LPH
• UDI-Device Identifier: 07630030811869
• UDI-Public: 07630030811869
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/06/2020

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: No Information
• Device Expiration Date: 08/28/2021
• Device Model Number: 01.32.3241HCAT
• Device Catalogue Number: 01.32.3241HCAT
• Device Lot Number: 163260
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 07/06/2020
• 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