MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER SLEEVE SIZE M; BALL HEAD SLEEVE

Model Number	01.29.241A
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 august 2020: lot 19c0018: (b)(4) items manufactured and released on 31-jan-2019.Expiration date: 2024-01-17.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.Other devices involved in the event: ball heads: mectacer 01.29.230h head biolox option ø 28 lot.1907389 (k131518) batch review performed on 18 august 2020: lot 1907389: (b)(4) items manufactured and released on 22-nov-2019.Expiration date: 2024-11-11.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.Liner: versafitcup dm 01.26.2854mhc double mobility hc liner ø 54/28 lot.1908430 (k092265).Batch review performed on 18 august 2020: lot 1908430: (b)(4) items manufactured and released on 19-dec-2019.Expiration date: 2024-12-07.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
The patient came in due to signs of an infection and the pathogen is unknown.2 months after primary the surgeon performed a washout and revised the head, sleeve, and liner.The surgery was completed successfully.

• Brand Name: BALL HEADS: MECTACER SLEEVE SIZE M
• Common Device Name: BALL HEAD SLEEVE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10487423
• Report Number: 3005180920-2020-00580
• Device Sequence Number: 16782386
• Product Code: LZO
• UDI-Device Identifier: 07630030809385
• UDI-Public: 07630030809385
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131518
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/03/2020

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: No Information
• Device Expiration Date: 01/17/2024
• Device Model Number: 01.29.241A
• Device Catalogue Number: 01.29.241A
• Device Lot Number: 19C0018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 09/03/2020
• 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