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

Model Number	01.18.143
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	02/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 february 2020.Lot 112383: (b)(4) items manufactured and released on 09-aug-2011.Expiration date: 2016-06-30.No anomalies found related to the problem.(b)(4) item re-sterilized and released on 24-jun-2016.Expiration date: 2021-06-07.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.Clinical evaluation performed by medical affairs director: partial hip revision (stem, head and liner) performed 7 years and 8 months after cementless double mobility total hip arthroplasty.In the radiographic images provided, osteolitic regions around the stem are visible.Osteolysis may be the consequence of polyethylene wear that is commonly seen and described in literature, however wear was not measured in this case and therefore correlation is not established.It is also possible that a bone resorption process has taken place (radiographic history not available), because in the pre-revision images the stem looks slightly undersized.Preliminary investigation performed by r&d project manager: from preliminary investigation of the images provided it is not possible to determine implant's failure root cause other implant invovled in the event: liner: versafitcup dm 01.26.2848mhc double mobility hc liner ø 48/28 (k092265) lot.113816 batch review performed on 06 march 2020 lot 113816: (b)(4) items manufactured and released on 02-feb-2012.Expiration date: 2016-12-31.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.
Event or Problem Description
The patient came in reporting pain.The surgeon took x-rays and determined the patient had loosening and distal potting.The surgeon revised the liner, head, and stem 7 years and 8 months after primary.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM H HA COATED LAT STEM SIZE 3
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9799442
• Report Number: 3005180920-2020-00129
• Device Sequence Number: 18993476
• 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: 2012
• 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): 03/06/2020

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: 06/30/2016
• Device Model Number: 01.18.143
• Device Catalogue Number: 01.18.143
• Device Lot Number: 112383
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 03/06/2020
• 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