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

Catalog Number	01.26.3244HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 october 2019.Lot 1900236: (b)(4) items manufactured and released on 14-mar-2019.Expiration date: 2024-03-03.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 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115) lot.189641.Batch review performed on 14 october 2019.Lot 189641: (b)(4) items manufactured and released on 21-feb-2019.Expiration date: 2024-02-07.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.
Event or Problem Description
During a follow up, the surgeon discovered that the patient had subcutaneous storage area with deeding of the wound on the distal part and imbibition of tissues and reddening.Few days later the patient was revised, liner and head were removed, probably due to infection, pathogen is staphylococcus aureus.The revision has been performed 20 days after primary surgery.

• Brand Name: LINER: CC E CC LIGHT FLAT PE HC LINER Ø 32 / E
• Common Device Name: ACETABULAR LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9255107
• Report Number: 3005180920-2019-00922
• Device Sequence Number: 14090814
• Product Code: LZO
• UDI-Device Identifier: 07630030807572
• UDI-Public: 07630030807572
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 10/30/2019

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: 03/03/2024
• Device Catalogue Number: 01.26.3244HCT
• Device Lot Number: 1900236
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 10/30/2019
• 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: 84