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

Catalog Number	01.32.3239HCT
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	09/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 october 2018.Lot 177535: (b)(4) items manufactured and released on 14 march 2018.Expiration date: 2023-02-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional component involved in the revision: ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115), lot 178802: (b)(4) items manufactured and released on 23 april 2018.Expiration date: 2023-04-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
On (b)(6) 2018 we were informed that the patient came in complaining of instability: the head had dislocated from the liner 2 months after the primary.The surgeon revised the head and liner on the following day.The surgeon determined the dislocation was caused by capsular impingement and not implant related.It was determined that more offset through the acetabular side or femoral side could have aided in making the patient more stable during index procedure.Because there was not enough offset the surgeon saw what he thought was an eccentric position of the head in the liner.With the absence of an offset liner and reluctance to pull a well fixed stem, the surgeon went to an elevated liner/and longer neck on the 32mm hip ball.

• Brand Name: LINER: MPACT FLAT PE HC LINER Ø32/C
• Common Device Name: HIP HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8000028
• Report Number: 3005180920-2018-00818
• Device Sequence Number: 13835714
• Product Code: LPH
• UDI-Device Identifier: 07630030811845
• UDI-Public: 07630030811845
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2018

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: 02/28/2023
• Device Catalogue Number: 01.32.3239HCT
• Device Lot Number: 177535
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 10/24/2018
• 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