MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC 36/G; ACETABULAR LINER

Model Number	01.32.3652HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 5 october 2021: lot 2009615: (b)(4) items manufactured and released on 22-oct-2020.Expiration date: 2025-oct-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Another devices involved: batch review performed on 5 october 2021: ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4 (k112115)lot.2012919: (b)(4) items manufactured and released on 08-apr-2021.Expiration date: 2026-mar-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4 (k112115) lot.2011671: (b)(4) items manufactured and released on 02-mar-2021.Expiration date: 2026-feb-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Liner: mpact 01.32.3652hct flat pe hc liner ø36/g (k103721) lot 2103129: (b)(4) items manufactured and released on 21-apr-2021.Expiration date: 2026-apr-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Cup: mpact 3d metal 01.38.060dh acetabular shell ø60 two-hole (k171966) lot 2010341: (b)(4) items manufactured and released on 25-feb-2021.Expiration date: 2026-feb-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event [1420-21].Stem: sms solid 01.36.049 sms solid stem std size 9 (k181693) lot 2100577: (b)(4) items manufactured and released on 28-apr-2021.Expiration date: 2026-apr-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Mpact 01.32.6525 cancellous bone screw, flat head ø 6,5 l 25 (k103721) lot.2103731:(b)(4) items manufactured and released on 5-may-2021.Expiration date: 2026-apr-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2021.On (b)(6) 2021, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the head and liner (lots: 2012919, 2009615).The surgery was completed successfully.On (b)(6) 2021, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all components (lots: 2011671,2103129, 2010341, 2100577, 2103731), and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: LINER: MPACT FLAT PE HC 36/G
• Common Device Name: ACETABULAR LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12719879
• Report Number: 3005180920-2021-00832
• Device Sequence Number: 1480048
• Product Code: LPH
• UDI-Device Identifier: 07630030812156
• UDI-Public: 07630030812156
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 10/29/2021

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: 10/08/2025
• Device Model Number: 01.32.3652HCT
• Device Catalogue Number: 01.32.3652HCT
• Device Lot Number: 2009615
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 10/29/2021
• 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