MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM COLLARED STEM COLLARED HA COATED LAT STEM SIZE 7; HIP CEMENTLESS STEM

Catalog Number	01.18.247
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	04/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 may 2019: lot 115655: (b)(4) items manufactured and released on 13-feb-2012.Expiration date: 2017-01-31.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.Clinical evaluation performed by medical affairs director: revision surgery occurred 6 years after cementless total hip arthroplasty in a (b)(6) year old man.No information concerning patient general health and presence of comorbidities is available.Reportedly, the cause for replacement is femoral inflammation, which is unclear.The images supplied are of little help.The information provided is not sufficient for a final assessment.Preliminary investigation performed by r&d project manager: few scratches on the femoral neck.From preliminary investigation it is not possible to highlight any particular sign related to the revision cause.
Event or Problem Description
Revision surgery performed 6 years and two months after primary surgery due to femoral inflammation.Stem and head have been revised.
Additional Manufacturer Narrative
On july 31st 2019 we received the information that the device is not available.
Additional Manufacturer Narrative
Visual inspection performed by medacta r&d hip project manager: from the received piece and information it is not possible to determine the root cause of the event, as no critical or particular signs were visible on the stem.

• Brand Name: STEM: AMISTEM COLLARED STEM COLLARED HA COATED LAT STEM SIZE 7
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8645813
• Report Number: 3005180920-2019-00430
• Device Sequence Number: 13890287
• Product Code: LZO
• UDI-Device Identifier: 07630030804724
• UDI-Public: 07630030804724
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2019

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: 01/31/2017
• Device Catalogue Number: 01.18.247
• Device Lot Number: 115655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 05/03/2019; 05/03/2019
• Initial Report FDA Received Date: 05/28/2019
• Supplement Report FDA Received Date: 07/31/2019; 10/17/2019
• 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: 69 YR
• Patient Weight: 87