MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM COLLARED STEM COLLARED HA COATED LAT STEM SIZE 1; CEMENTLESS HIP STEM

Catalog Number	01.18.241
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 february 2019: lot 152565: (b)(4) items manufactured and released on 15-jul-2015.Expiration date: 2020-05-31.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 devices involved: mectacer reference 01.29.203 (k112115) biolox delta ceramic ball head 12/14 ø 28 size l +3.5 lot 161742: (b)(4) items manufactured and released on 11-may-2016.Expiration date: 2021-04-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with 2 other similar reported events.Versafitcup dm reference 01.26.2852mhc (k092265) double mobility hc liner ø 52/28.Lot 157671: (b)(4) items manufactured and released on 04-apr-2016.Expiration date: 2021-03-09.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.Versafitcup 01.26.52mb (k083116) acetabular shell ø 52.Lot 160204: (b)(4) items manufactured and released on 25-apr-2016.Expiration date: 2021-04-12.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.
Event or Problem Description
About 2 years and 2 months after primary the surgeon revised all the patient hardware for infection.Antibiotic spacer inserted.The surgery was completed successfully.

• Brand Name: AMISTEM COLLARED STEM COLLARED 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: 8331034
• Report Number: 3005180920-2019-00048
• Device Sequence Number: 1650266
• Product Code: LZO
• UDI-Device Identifier: 07630030804663
• UDI-Public: 07630030804663
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 02/12/2019

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: 05/31/2020
• Device Catalogue Number: 01.18.241
• Device Lot Number: 152565
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2019
• Initial Report FDA Received Date: 02/12/2019
• 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