MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 8; CEMENTLESS STEM

Catalog Number	01.18.438
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 may 2021: lot 186915: (b)(4) items manufactured and released on 15-nov-2018.Expiration date: 2023-11-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional items involved in the event: liner: versafitcup dm 01.26.2854mhc double mobility hc liner ø 54/28 (k092265) lot.2003322.Batch review performed on 10 may 2021: lot 2003322: (b)(4) items manufactured and released on 23-jul-2020.Expiration date: 2025-07-13.No anomalies found related to the problem.To date, (b)(4) 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) lot.2007621.Batch review performed on 10 may 2021: lot 2007621: (b)(4) items manufactured and released on 30-oct-2020.Expiration date: 2025-10-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in reporting pain and instability due to a leg length discrepancy.The cause of the leg length discrepancy is unknown.The surgeon revised the stem, head and liner 3 days after primary.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 8
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11795931
• Report Number: 3005180920-2021-00369
• Device Sequence Number: 4017530
• Product Code: LZO
• UDI-Device Identifier: 07630040720274
• UDI-Public: 07630040720274
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 05/10/2021

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: 04/11/2023
• Device Catalogue Number: 01.18.438
• Device Lot Number: 186915
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 05/10/2021
• 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