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

Catalog Number	01.18.142
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	04/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 may 2019: lot 103219: (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 with another similar reported event.Clinical evaluation performed by medical affairs manager: partial hip revision surgery (stem, head and liner) occured 8 years after cementless total hip arthroplasty in a (b)(6) year old woman.Radiographic image provided shows the presence of radiolucent lines in gruen zones 1 and 2 and signs of stress shielding suggesting implant mobilization.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.Preliminary investigation performed by medacta r&d hip project manager: pe liner shows debris of unknown reason (due to removal process or impingement events?).The material is probably coming from the internal equatorial edge.Visual inspection performed by medacta r&d hip project manager: ha layer still intact on the proximal part of the implant on few sides.Femoral neck and pe liner show signs of extraction.
Event or Problem Description
Revision performed after 8 years and 1 month form the primary due to pain caused by an aseptic loosening of the amistem lat size 2.During the revision the stem, the head and the inlay were changed.

• Brand Name: STEM: AMISTEM H HA COATED LAT STEM SIZE 2
• Common Device Name: UNCEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8649827
• Report Number: 3005180920-2019-00414
• Device Sequence Number: 2039467
• Product Code: LZO
• UDI-Device Identifier: 07630030804182
• UDI-Public: 07630030804182
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 05/29/2019

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: 10/31/2015
• Device Catalogue Number: 01.18.142
• Device Lot Number: 103219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 05/29/2019
• 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: 66 YR
• Patient Weight: 70