MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL; ACETABULAR CEMENTLESS SHELL

Catalog Number	01.26.52MB
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 22 dec 2017 the medical affairs made the following analysis: late infection in cementless tha, 7 months after primary operation.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.Batch reviews performed on 02 january 2018: lot 163140: (b)(4) items manufactured and released on 15 september 2016.Expiration date: 2021-08-29.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Amistem h ha coated std stem #6 ref.01.18.136 lot.165573 (k093944): lot 165573: (b)(4) items manufactured and released on 21 december 2016.Expiration date: 2021-12-04.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Versafitcup dm c liner ø 52/28 ref.01.26.2852mhc lot.162321 (k092265): lot 162321: (b)(4) items manufactured and released on 25 july 2016.Expiration date: 2021-06-29.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold with 2 similar reported events.Cocr ball head 12/14 ø 28 size m ref.01.25.012 lot.164835 (k072857): lot 164835: (b)(4) items manufactured and released on 17 october 2016.Expiration date: 2021-10-04.No anomalies found related to the issue.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 infection is confirmed as rare beta hemolytic streptococci.The surgeon removed all medacta hardware and implanted a spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
The second step of the revision was completed on (b)(6) 2018.The surgeon removed the spacer and implanted permanent product.The surgery was completed successfully.

• Brand Name: VERSAFITCUP ACETABULAR SHELL
• Common Device Name: ACETABULAR CEMENTLESS SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7160289
• Report Number: 3005180920-2017-00805
• Device Sequence Number: 11097891
• Product Code: MEH
• UDI-Device Identifier: 07630030808098
• UDI-Public: 07630030808098
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2018

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: 08/29/2021
• Device Catalogue Number: 01.26.52MB
• Device Lot Number: 163140
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 05/17/2018
• 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