MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: CC E CC LIGHT FLAT PE HC LINER 36 / F; ACETABULAR PE LINER

Model Number	01.26.3648HCT
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 18 march 2020: lot 123606: (b)(4) items manufactured and released on 16-oct-2012.Expiration date: 2017-08-31.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 since 2016.Additional implant involved: ball heads: cocr 01.25.033 cocr ball head 12/14 ø 36 size xl +7 (k080885) lot.110379.Batch review performed by medacta regulatory affairs department on 18 march 2020: lot 110379: (b)(4) items manufactured and released on 13-apr-2011.Expiration date: 2016-02-28.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 since 2016.
Event or Problem Description
Revision surgery performed after 7 years and 3 months from the primary.The surgeon revised the cup, head and liner and replace them with a dual mobility cup due to dislocation the head from the liner due to the patient weight.The stem was not revised.

• Brand Name: LINER: CC E CC LIGHT FLAT PE HC LINER 36 / F
• Common Device Name: ACETABULAR PE LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9961668
• Report Number: 3005180920-2020-00236
• Device Sequence Number: 10882761
• Product Code: LZO
• UDI-Device Identifier: 07630030807688
• UDI-Public: 07630030807688
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2020

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: 08/31/2017
• Device Model Number: 01.26.3648HCT
• Device Catalogue Number: 01.26.3648HCT
• Device Lot Number: 123606
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 04/15/2020
• 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
• Patient Age: 61 YR
• Patient Weight: 175