MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT STEM SIZE 3; CEMENTLESS HIP STEM

Model Number	01.18.143
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	08/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20-aug-2020: lot 103236: (b)(4) items manufactured and released on 23-nov-2010.Expiration date: 31.10.2015.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 since 2016.Additional implant involved: ball heads: cocr 01.25.012 cocr ball head 12/14 ø 28 size m 0 (k072857) lot.132343.Batch review performed on 09-sep-2020: lot 132343: (b)(4) items manufactured and released on 03-jul-2013.Expiration date: 31-may-2018.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.Additional implant involved: liner: versafitcup dm 01.26.2860mhc double mobility hc liner ø 60/28 (k092265) lot.114609.Batch review performed on 09-sep-2020: lot 114609: (b)(4) items manufactured and released on 18-feb-2012.Expiration date: 31-jan-2017.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 since 2016.
Event or Problem Description
The patient came in reporting discomfort 6 years and 8 months after the primary.The cause of the discomfort is unknown.The surgeon revised the stem, head, and liner.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM H HA COATED LAT STEM SIZE 3
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10507114
• Report Number: 3005180920-2020-00584
• Device Sequence Number: 3507604
• Product Code: LZO
• UDI-Device Identifier: 07630030804199
• UDI-Public: 07630030804199
• 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: 2013
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2020

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: 10/31/2015
• Device Model Number: 01.18.143
• Device Catalogue Number: 01.18.143
• Device Lot Number: 103236
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 09/09/2020
• 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