MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA H CEMENTLESS STEM; FEMORAL CEMENTLESS STEM SIZE 2 SHORT NECK

Catalog Number	01.12.22SN
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 july 2017.Lot 155685: (b)(4) items manufactured and released on 18 march 2016.Expiration date: 2021-03-03.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.Mectacer biolox delta ceramic ball head 12/14 ø 28 size s -3.5, code 01.29.201 lot.155931 (k112115): (b)(4) items manufactured and released on 18 january 2016.Expiration date: 2021-01-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold and this is the second similar event reported on this lot.Versafitcup dm double mobility hc liner ø 52/28 code 01.26.2852mhc lot.154846 (k092265): (b)(4) items manufactured and released on 26 november 2015.Expiration date: 2020-11-08.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.Versafitcup acetabular shell ø 52 code 01.26.52mb lot.155802 (k083116): 70 items manufactured and released on 25 january 2016.Expiration date: 2021-01-10.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.
Event or Problem Description
Revision of all the implants due to suspected infection 1 year and 1 month after primary.The surgeon implanted a stem and dm liner and metal head during the first step of the revision surgery, as there was not any cement spacers available at the hospital.No cup was implanted.When the infection is cleared these components will be removed and the definitive ones implanted.

• Brand Name: QUADRA H CEMENTLESS STEM
• Common Device Name: FEMORAL CEMENTLESS STEM SIZE 2 SHORT NECK
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6762725
• Report Number: 3005180920-2017-00430
• Device Sequence Number: 16516514
• Product Code: JDI
• UDI-Device Identifier: 07630030802621
• UDI-Public: 07630030802621
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• 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: 03/03/2021
• Device Catalogue Number: 01.12.22SN
• Device Lot Number: 155685
• 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: 07/05/2017
• 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
• Patient Age: 63 YR