MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø54 MULTI-HOLE

Model Number 01.32.154MH

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Joint Disorder (2373)

Event Date 05/26/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed by medacta regulatory affairs department on 5 june 2020: lot 153878: (b)(4) items manufactured and released on 11-jan-2016.Expiration date: 2020-12-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with no other similar reported event.Additional implant involved: ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4 (k112115) lot.176831.Batch review performed by medacta regulatory affairs department on 5 june 2020: lot 176831: (b)(4) items manufactured and released on 05-mar-2018.Expiration date: 2023-02-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with no other similar reported event.Additional implant involved: liner: mpact 01.32.3644hct flat pe hc liner ø36/e (k103721) lot.179363.Batch review performed by medacta regulatory affairs department on 5 june 2020: lot 179363: (b)(4) items manufactured and released on 05-apr-2018.Expiration date: 2023-03-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with no other similar reported event.

Event Description

The patient came in 1 year and 10 months after the primary surgery reporting a leg length discrepancy.The surgeon revised the 36mm biolox head with a 28mm biolox head and revised the medacta cup and liner with another company's cup and liner.The surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø54 MULTI-HOLE
• Type of Device: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 10183414
• MDR Text Key: 197746174
• Report Number: 3005180920-2020-00350
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07630030810831
• UDI-Public: 07630030810831
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/23/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2020
• Device Model Number: 01.32.154MH
• Device Catalogue Number: 01.32.154MH
• Device Lot Number: 153878
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 06/23/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR