MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT DM CONVERTER LINER F/DME; HIP DOUBLE MOBILITY CONVERTER LINER

Model Number	01.32.4248MC
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 november 2020: lot 1903438: (b)(4) items manufactured and released on 20-nov-2019.Expiration date: 2024-11-10.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 device involved: batch reviews performed on 19 november 2020: cup: mpact 01.32.156mh acetabular shell ø56 multi-hole (k132879) batch review performed on 19 november 2020: lot 1903438: (b)(4) items manufactured and released on 12-sep-2019.Expiration date: 2024-08-28.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.Liner: versafitcup dm 01.26.2850mhc double mobility hc liner ø 50/28 (k092265) lot 1910312: (b)(4) items manufactured and released on 18-feb-2020.Expiration date: 2025-02-03.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
The patient had primary hip surgery and was implanted with competitor products.On (b)(6) 2020, the patient came in and had the competitor products revised for reasons unknown.The patient was implanted with a medacta cup and liner.On (b)(6) 2020, the patient came in reporting pain due to a dislocation of the double mobility polyethylene liner from the liner and a dissociation of the dm converted from the cup that occurred while the patient was using the bathroom and tried to stand from being in a seated position.The surgeon revised the medacta liner and cup, and competitor head all with competitor products.The surgery was completed successfully.

• Brand Name: LINER: MPACT DM CONVERTER LINER F/DME
• Common Device Name: HIP DOUBLE MOBILITY CONVERTER LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10957241
• Report Number: 3005180920-2020-00869
• Device Sequence Number: 14058398
• Product Code: LZO
• UDI-Device Identifier: 07630030812323
• UDI-Public: 07630030812323
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131458
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2020

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: 11/10/2024
• Device Model Number: 01.32.4248MC
• Device Catalogue Number: 01.32.4248MC
• Device Lot Number: 1903443
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2020
• Initial Report FDA Received Date: 12/07/2020
• 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