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

Catalog Number	01.26.3648HCT
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 march 2019: lot 176500: (b)(4) items manufactured and released on 23-jan-2018.Expiration date: 2023-01-08.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 implant involved: ball heads: mectacer 01.29.232h head biolox option ø 36 (k131518) lot 176859: 30 items manufactured and released on 20-dec-2017.Expiration date: 2022-12-11.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.Preliminary investigation performed by r&d project manager: from preliminary investigation, it is not possible to determine an implant-related failure root cause.
Event or Problem Description
About 3 months after primary revision the surgeon revised the patient for hip dislocation (head from liner) due to a gluteal repair rupture.Revision has been performed successfully using competitor constrained cup and liner and medacta head.Surgeon commented that there was great bone in growth on cup and needed explant to get out.

• Brand Name: LINER: CC E CC LIGHT FLAT PE HC LINER Ø 36 / F
• Common Device Name: FLAT PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8464662
• Report Number: 3005180920-2019-00202
• Device Sequence Number: 222616
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2019

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: 01/08/2023
• Device Catalogue Number: 01.26.3648HCT
• Device Lot Number: 176500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 03/29/2019
• 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
• Patient Age: 70 YR
• Patient Weight: 100