MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H COATED LAT STEM SIZE 8; HIP UNCEMENTED STEM

Model Number	01.18.148
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	02/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 march 2020: lot 103214: (b)(4) items manufactured and released on 13-dec-2010.Expiration date: 2015-11-30.No anomalies found related to the problem.(b)(4) item resterilized and released on 08-feb-2012.Expiration date: 2016-12-31.No anomalies found related to the problem.(b)(4) item resterilized and released on 24-jan-2013.Expiration date: 2017-12-31.No anomalies found related to the problem.(b)(4) items resterilized and released on 01-mar-2013.Expiration date: 2018-01-31.No anomalies found related to the problem.(b)(4) item resterilized and released on 18-apr-2013.Expiration date: 2018-03-31.No anomalies found related to the problem.(b)(4) item resterilized and released on 29-sep-2015.Expiration date: 2020-09-06.No anomalies found related to the problem.(b)(4) item resterilized and released on 01-nov-2015.Expiration date: 2020-10-20.No anomalies found related to the problem.(b)(4) items resterilized and released on 09-jun-2016.Expiration date: 2021-05-17.No anomalies found related to the problem.(b)(4) items resterilized and released on 06-jul-2016.Expiration date: 2021-06-22.No anomalies found related to the problem.(b)(4) item resterilized and released on 27-oct-2016.Expiration date: 2021-10-11.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.Clinical evaluation performed by medacta clinical affairs director: hip revision surgery performed 8 years after cementless total hip arthroplasty.No information concerning patient age, general health conditions and activity level is available.Radiographic image provided shows the presence of osteolytic areas in gruen zone 1 and suboptimal cup position.We cannot tell if this is the result of post-surgery migration or the surgeon's choice: in the latter case, no explanation for this decision was supplied.The reason of this event cannot be determined.
Event or Problem Description
The patient came in reporting pain due to a loose stem.The cause of the loose stem is unknown.The surgeon revised the stem and cup 8 years and 2 months after primary.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM H COATED LAT STEM SIZE 8
• Common Device Name: HIP UNCEMENTED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9834853
• Report Number: 3005180920-2020-00161
• Device Sequence Number: 13840752
• Product Code: LZO
• UDI-Device Identifier: 07630030804243
• UDI-Public: 07630030804243
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/16/2020

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: 12/31/2016
• Device Model Number: 01.18.148
• Device Catalogue Number: 01.18.148
• Device Lot Number: 103214
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 03/16/2020
• 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