MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT 01.32.3648HCAT HOODED PE HC LINER Ø36/F; HIP LINER PE HC

Catalog Number	01.32.3648HCAT
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25-july-2019: lot 179370: (b)(4) items manufactured and released on 08-may-2018.Expiration date: 2023-04-18.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 implant: ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 lot.186548 (k112115).Batch review performed on 25-july-2019: lot 186548: (b)(4) items manufactured and released on 29-nov-2018.Expiration date: 2023-11-14.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
On the same day of the primary surgery, it was observed that the patient was in pain due to a dislocation of the head from the liner.The surgeon revised the 36mm biolox delta head m with a 40mm biolox delta head m and revised the mpact hooded liner hc 36/f with a mpact flat liner hc 40/f.The surgery was completed successfully.

• Brand Name: LINER: MPACT 01.32.3648HCAT HOODED PE HC LINER Ø36/F
• Common Device Name: HIP LINER PE HC
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8878378
• Report Number: 3005180920-2019-00678
• Device Sequence Number: 19365159
• Product Code: LPH
• UDI-Device Identifier: 07630030812125
• UDI-Public: 07630030812125
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• 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: 04/18/2023
• Device Catalogue Number: 01.32.3648HCAT
• Device Lot Number: 179370
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2019
• 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