MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT STEM SIZE 2; HIP CEMENTLESS STEM

Catalog Number	01.18.142
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 march 2019: lot 113179: (b)(4) items manufactured and released on 19-dec-2011.Expiration date: 2016-09-30.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.Visual inspection performed by r&d project manager: as stated by the surgeon, the loosening outcome is in line with the preliminary visual inspection of the implant.After almost 7 years in situ, no ha resorption on the proximal part, suggests fixation and load transfer on the distal part of the stem.Clinical evaluation performed by medical affairs director: hip revision surgery occurred 6 years and 5 months after primary total hip arthroplasty in a (b)(6) year old man.Radiographic images provided show radiolucent lines around the stem and signs of stress shielding suggesting implant mobilization.The picture of the retrieved stem shows the absence of hydroxyapatite coating in the distal part of the stem probably due to distal fixation.Aseptic loosening is a possible, literature described adverse event after cementless total hip arthroplasty and causes are often unknown.The reason of this event cannot be determined.
Event or Problem Description
Revision surgery performed due to stem loosening 6 years and 5 months after primary.After the revision, some coating was found attached to the stem.The histological analysis outcome was negative.

• Brand Name: STEM: AMISTEM H HA COATED LAT STEM SIZE 2
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8464674
• Report Number: 3005180920-2019-00215
• Device Sequence Number: 10818520
• Product Code: LZO
• UDI-Device Identifier: 07630030804182
• UDI-Public: 07630030804182
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2019

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: 09/30/2016
• Device Catalogue Number: 01.18.142
• Device Lot Number: 113179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2019
• Initial Report FDA Received Date: 03/29/2019
• 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: 63 YR
• Patient Weight: 90