MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H 01.18.134 HA COATED STD STEM SIZE 4; HIP STEM

Model Number	01.12.021
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2020.Lot 122552: 60 items manufactured and released on 11-sep-2012.Expiration date: 2017-07-31.No anomalies found related to the problem.1 item released on 01-mar-2013.Expiration date: 2018-01-31.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 since 2016.Clinical evaluation: 8 years after primary bilateral cementless tha the sfemoral stem is found loose and needs to be revised.This patient had exactly the same adverse event on the contralateral side too.There is probably a lack of osteointegration at the proximal part of the stem: cause unknown.No radiographic history is available toevaluate the evoltuion of the situation.Aseptic loosening is a possible adverse event following tha, described in literature, and causes are often unknown.No reason to suspect a faulty device.Oher device involved in the event ball heads: cocr 01.25.031 cocr ball head 12/14 ø 36 size m 0 lot.123106 (k080885).Batch review performed on (b)(6) 2020.Lot 123106: 25 items manufactured and released on 24-sep-2012.Expiration date: 2017-08-31.No anomalies found related to the problem.To date, 24 items of the same lot have been already sold without any other similar reported event since 2016.
Event or Problem Description
The patient came in reporting pain and the cause of the pain is unknown.The surgeon revised the stem and head with a competitor stem and head almost 8 years and 1 month after primary.The surgery was completed successfully.Patient's left hip was revised.The patient previously came in and had the right hip revised with the exact same issue.

• Brand Name: STEM: AMISTEM H 01.18.134 HA COATED STD STEM SIZE 4
• Common Device Name: HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10959340
• Report Number: 3005180920-2020-00877
• Device Sequence Number: 14058397
• Product Code: LZO
• UDI-Device Identifier: 07630030802027
• UDI-Public: 07630030802027
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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): 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: 01.12.021
• Device Catalogue Number: 01.18.134
• Device Lot Number: 122552
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 12/07/2020
• 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