MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER 32 / E; ACETABULAR PE LINER

Model Number	01.26.3244HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 august 2020: lot 1901442: (b)(4) items manufactured and released on 17-apr-2019.Expiration date: 2024-04-07.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: cup: versafitcup cc trio 01.26.45.0054 acetabular shell cc trio ø 54 (k103352) lot.1901419.Batch review performed on 21 august 2020: lot 1901419: (b)(4) items manufactured and released on 10-may-2019.Expiration date: 2024-04-30.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: stem: quadra-h 01.12.025 cementless, ha coated std stem size 5 (k082792) lot.1905392.Batch review performed on 21 august 2020: lot 1905392: (b)(4) items manufactured and released on 08-oct-2019.Expiration date: 2024-09-03.No anomalies found related to the problem.To date all the items of the same lot have been already sold without any similar reported event.Additional implant involved: ball heads: mectacer 01.29.204 biolox delta ceramic ball head 12/14 ø 32 size s -4 (k112115) lot.1905637.Batch review performed on 21 august 2020: lot 1905637: (b)(4) items manufactured and released on 03-oct-2019.Expiration date: 2024-09-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event.
Event or Problem Description
The patient has a low grade infection with staphylococcus epidermidis.7 months after primary the surgeon explanted successfully all the devices.

• Brand Name: LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER 32 / E
• Common Device Name: ACETABULAR PE LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10482178
• Report Number: 3005180920-2020-00575
• Device Sequence Number: 11785295
• Product Code: LZO
• UDI-Device Identifier: 07630030807572
• UDI-Public: 07630030807572
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 09/02/2020

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: 04/07/2024
• Device Model Number: 01.26.3244HCT
• Device Catalogue Number: 01.26.3244HCT
• Device Lot Number: 1901442
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 09/02/2020
• 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: 73 YR
• Patient Weight: 150