MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM COLLARED STEM HA COATED STD STEM SIZE 3; HIP STEM

Model Number	01.18.233
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 november 2020, lot 180040: (b)(4) items manufactured and released on 30-may-2018.Expiration date: 21-may-2023.No anomalies found related to the problem to date, all items of the same lot have been already sold without any other similar reported event.Other devices involved in the event: cup: versafitcup 01.26.50mb acetabular shell ø 50 lot.177473 (k083116), batch review performed on 11 november 2020, lot 177473:(b)(4) items manufactured and released on 02-mar-2018.Expiration date: 22-feb-2023.No anomalies found related to the problem to date, all items of the same lot have been already sold without any other similar reported event, liner: versafitcup dm 01.26.2850mhc double mobility hc liner ø 50/28 lot.178296 (k092265), batch review performed on 11 november 2020, lot 178296: (b)(4) items manufactured and released on 22-mar-2018.Expiration date: 09-mar-2023.No anomalies found related to the problem to date, all items of the same lot have been already sold without any other similar reported event, ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 (k112115), batch review performed on 11 november 2020, lot 174689: (b)(4) items manufactured and released on 05-january-2018.Expiration date: 18-dec-2022 no anomalies found related to the problem.To date, 127 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in reporting pain, the cause of the pain is unknown, 2 years and 2 months after the primary surgery.The surgeon removed all revised all components and the surgery was completed successfully.

• Brand Name: STEM: AMISTEM COLLARED STEM HA COATED STD STEM SIZE 3
• Common Device Name: HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10822489
• Report Number: 3005180920-2020-00791
• Device Sequence Number: 2938235
• Product Code: LZO
• UDI-Device Identifier: 07630030804588
• UDI-Public: 07630030804588
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/10/2020

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: 05/21/2023
• Device Model Number: 01.18.233
• Device Catalogue Number: 01.18.233
• Device Lot Number: 180040
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 11/11/2020
• 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