MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SHELL; CEMENTLESS ACETABULAR SHELL Ø 56

Catalog Number	01.26.45.0056
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 31 july 2017: lot 155366: (b)(4) items manufactured and released on 18 january 2016.Expiration date: 2021-01-05.No anomalies found related to the reported issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Cancellous bone screw flat head ø 6,5 l 25 code 01.26.65.25 lot.154186 (k103352): (b)(4) items manufactured and released on 06 october 2015.Expiration date: 2020-08-31.No anomalies found related to the reported issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Cancellous bone screw flat head ø 6,5 l 30 code 01.26.65.30 lot.153635 (k103352): (b)(4) items manufactured and released on 09 september 2015.Expiration date: 2020-06-30.No anomalies found related to the reported issue.To date, (b)(4) items of the same lot have been already sold with 1 similar reported event.Versafitcup cc trio flat pe hc liner ø 36/f code 01.26.3648hct lot.142649 (k103352): (b)(4) items manufactured and released on 26 july 2014.Expiration date: 2019-05-31.No anomalies found related to the reported issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Mectacer biolox delta ceramic ball head 12/14 ø 36 size s code 01.29.208 lot.155936 (k112115): (b)(4) items manufactured and released on 20 january 2016.Expiration date: 2021-01-06.No anomalies found related to the reported issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Amistem h collared ha coated std stem #4 code 01.18.234 lot.155248 (k121011): (b)(4) items manufactured and released on 15 january 2016.Expiration date: 2021-01-02.No anomalies found related to the reported 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 pathogen is unknown.The surgeon removed all medacta hardware and implanted an antibiotic spacer.The surgery was completed successfully.X-rays and explants are not available.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SHELL
• Common Device Name: CEMENTLESS ACETABULAR SHELL Ø 56
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6763321
• Report Number: 3005180920-2017-00439
• Device Sequence Number: 19205338
• Product Code: LZO
• UDI-Device Identifier: 07630030807794
• UDI-Public: 07630030807794
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/03/2017

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: 01/05/2021
• Device Catalogue Number: 01.26.45.0056
• Device Lot Number: 155366
• 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: 07/11/2017
• Initial Report FDA Received Date: 08/03/2017
• 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