MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: 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	03/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information provided by the agent on 05.April.2019: during stem extraction occurred a complication, the large trochanter broke (cerclage), probably due to a bad quality bone.Only stem and ball head were explanted during the revision surgery.Batch review performed on 23 april 2019.Lot 161434: (b)(4) items manufactured and released on 16-jun-2016.Expiration date: 2021-05-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event clinical evaluation performed by medical affairs manager: partial hip revision surgery (stem and head) occurred 2 years after total hip arthroplasty in a (b)(6) year old, (b)(6) kg man complaining about pain and instability.Radiographic image provided shows a low resection height but the relation of this finding with patient symptoms is not clear.No sign of radiological mobilization is visible in this projection.The reason of this event cannot be determined.Visual inspection performed by r&d project manager: femoral stem and neck show signs of extraction.Bone residual on the distal part of the stem.Some ha remaining on the proxiamal part.It is not possible to determine implants-related failure root cause.
Event or Problem Description
Revision surgery after 2 years and 1 month from the primary due to pain and instability (radiolucencies of an amistem ha coated 1 lateralized cementless were detected).Revision surgery performed implanting a quadra-c stem 1 lateralized + plug 1.

• Brand Name: STEM: 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: 8544517
• Report Number: 3005180920-2019-00302
• Device Sequence Number: 13543227
• 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: 2017
• 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): 04/24/2019

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: 05/26/2021
• Device Catalogue Number: 01.18.141
• Device Lot Number: 161434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/24/2019
• 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: 53 YR
• Patient Weight: 98