MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM COLLARED HA COATED STD STEM SIZE 3; CEMENTLESS HIP STEM

Catalog Number	01.18.233
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 april 2018.Lot 170844: (b)(4) items manufactured and released on (b)(4) 2017.Expiration date: 2022-03-28 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.Others devices involved: versafitcup 01.26.48mb (k083116) acetabular shell ø 48; lot 166338: (b)(4) items manufactured and released on (b)(4) 2017.Expiration date: 2022-01-10.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 dm 01.26.2848mhc (k092265) double mobility hc liner ø 48/28; lot 166698: (b)(4) items manufactured and released on (b)(4) 2017.Expiration date: 2022-01-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with two similar reported event.Mectacer 01.29.201 (k112115), biolox delta ceramic ball head 12/14 ø 28 size s -3.5; lot 170679: (b)(4) items manufactured and released on (b)(4) 2017.Expiration date: 2022-05-14 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 7 months after primary.The patient was (b)(6) for (b)(6).All implants were removed and a spacer was implanted.The surgery was completed successfully.

• Brand Name: STEM COLLARED HA COATED STD STEM SIZE 3
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7464053
• Report Number: 3005180920-2018-00278
• Device Sequence Number: 1630181
• Product Code: LZO
• UDI-Device Identifier: 07630030804588
• UDI-Public: 07630030804588
• 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: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/30/2018

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: 03/28/2022
• Device Catalogue Number: 01.18.233
• Device Lot Number: 170844
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2018
• Initial Report FDA Received Date: 04/26/2018
• 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