MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-H PROXIMAL COATING STD STEM SIZE 5; CEMENTLESS HIP STEM

Catalog Number	01.18.175
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 september 2018.Lot 180062: (b)(4) items manufactured and released on 08 march 2018 expiration date: 2023-04-26 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.Other device involved: biolox delta ceramic ball head 12/14 ø 32 size m 0 reference 01.29.205.Lot 178996: (b)(4) items manufactured and released on 11 may 2018.Expiration date: 2023-04-29 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.Visual inspection performed by r&d project manager on 29 august 2018.Femoral stem and head do not show any particular sign to report except for the extraction procedure marks and scratches.Failure cause due to leg length discrepancy.
Event or Problem Description
The patient came in complaining of a leg length discrepancy 15 days after primary surgery.The surgeon revised the head and stem.

• Brand Name: AMISTEM-H PROXIMAL COATING STD STEM SIZE 5
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7854961
• Report Number: 3005180920-2018-00664
• Device Sequence Number: 16761452
• Product Code: LZO
• UDI-Device Identifier: 07630030804403
• UDI-Public: 07630030804403
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 09/07/2018

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: 04/26/2023
• Device Catalogue Number: 01.18.175
• Device Lot Number: 180062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 09/07/2018
• 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