MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM C, CEMENTED STEM SIZE 3 STD; CEMENTED FEMORAL STEM

Catalog Number	01.18.153
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch reviews performed on 10 july 2017.Lot 167523: (b)(4) items manufactured and released on 12 april 2017.Expiration date: 2022-03-27.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 double mobility hc liner ø 52/28, code 01.26.2852mhc, lot.157123 (k092265) (b)(4) items manufactured and released on 10 march 2016.Expiration date: 2021-02-20.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.Cocr ball head 12/14 ø 28 size s -3.5, code 01.25.011, lot.166588 (k072857) (b)(4) items manufactured and released on 07 march 2017.Expiration date: 2022-02-20.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.
Event or Problem Description
The patient came in due to signs of infection.The surgeon washed out the hip and removed the head, liner and stem.The surgeon closed the patient up.On (b)(6) 2017 the surgeon implanted a new medacta stem, head and liner.The surgery was completed successfully.X-rays and explants are not available.

• Brand Name: AMISTEM C, CEMENTED STEM SIZE 3 STD
• Common Device Name: CEMENTED FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6716893
• Report Number: 3005180920-2017-00384
• Device Sequence Number: 999552
• Product Code: LZO
• UDI-Device Identifier: 07630030804281
• UDI-Public: 07630030804281
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2017

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: 03/27/2022
• Device Catalogue Number: 01.18.153
• Device Lot Number: 167523
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2017
• Initial Report FDA Received Date: 07/17/2017
• 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: 80 YR