MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE 5; CEMENTLESS HIP STEM

Catalog Number	01.18.235
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 december 2018 lot 178480: (b)(4) items manufactured and released on 27 march 2018.Expiration date: 2023-03-08.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.Additional components involved: batch review performed on 07 december 2018: ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 (k112115).Lot 174689: (b)(4) items manufactured and released on 05-january-2018.Expiration date: 2022-12-18.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.Liner: mpact dm 01.26.2848mhc double mobility hc liner ø 48/28 (k092265).Lot.178295: (b)(4) items manufactured and released on 21-mar-2018.Expiration date: 2023-03-05.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
On november 9, 2018 we were informed that a patient came in due to signs of infection 3 months after the primary surgery and the pathogen was unknown.The surgeon planned to revise the stem, head and liner.The revision was planned for the week (b)(6) 2018, but no further information "have" been received.

• Brand Name: AMISTEM COLLARED STEM COLLARED HA COATED 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: 8141709
• Report Number: 3005180920-2018-00978
• Device Sequence Number: 16621898
• Product Code: LZO
• UDI-Device Identifier: 07630030804601
• UDI-Public: 07630030804601
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/07/2018

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: 03/08/2023
• Device Catalogue Number: 01.18.235
• Device Lot Number: 178480
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 12/07/2018
• 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