MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H HA COATED LAT STEM SIZE 1; CEMENTLESS HIP STEM

Catalog Number	01.18.141
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	12/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 january 2019: lot 092776: (b)(4) items manufactured and released on 17-feb-2010.Expiration date: 2014-12-31.No anomalies found related to the problem.To date, all the items of this same lot have been already sold without any similar reported event.Clinical investigation performed by medical affairs manager on december 20, 2018 partial hip revision surgery (stem and head) occurred 7 years and 10 months after primary cementless total hip arthroplasty in a (b)(6) year old man.Poor quality of radiographic image provided doesn't allow a proper evaluation of stem position and surrounding bone status.Aseptic loosening is a possible, literature described adverse event after cementless hip replacements and causes are often unknown.The reason of this event cannot be determined.Preliminary investigation performed by r&d product manager on december 18, 2018 picture shows stem and ceramic head covered in biological fluids.It is not possible to determine failure root cause.
Event or Problem Description
About 6 years and 8 months after primary the surgeon revised the patient hip for stem loosening.The surgery was completed successfully.

• Brand Name: AMISTEM H HA COATED LAT STEM SIZE 1
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8230877
• Report Number: 3005180920-2018-01075
• Device Sequence Number: 10816929
• Product Code: LZO
• UDI-Device Identifier: 07630030804175
• UDI-Public: 07630030804175
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2019

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: 12/31/2014
• Device Catalogue Number: 01.18.141
• Device Lot Number: 092776
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 01/09/2019
• 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
• Patient Age: 61 YR