MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-C CEMENTED, MIRROR POLISHING STD STEM SIZE 1 12/14; CEMENTED HIP STEM

Catalog Number	01.12.041
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 july 2019: lot 164578: (b)(4) items manufactured and released on 29 september 2016.Expiration date: 2021-09-20.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 implant involved: cup: versafitcup 01.26.50mb acetabular shell ø 50 (k083116) lot.177473.Batch review performed on 18/07/2019: lot 177473: (b)(4) items manufactured and released on 02-mar-2018.Expiration date: 2023-02-22.No anomalies found related to the problem to date, items of the same lot have been already sold without any other similar reported event.Additional implant involved: liner: versafitcup dm 01.26.2850mhc double mobility hc liner ø 50/28 (k092265) lot.178296.Batch review performed on 18/07/2019: lot 178296: (b)(4) items manufactured and released on 22-mar-2018.Expiration date: 2023-03-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional implant involved: mectaplug 01.33.101 mectaplug pe size 1 lot.180521 (not distributed in the us).Batch review performed on 18/07/2019: lot 180521: (b)(4) items manufactured and released on 25 apr 2018.Expiration date: 2023-04-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional implant involved: cup: ball heads: cocr 01.25.013 cocr ball head 12/14 ø 28 size l +3.5 (k072857) lot.166592.Batch review performed on 18 july 2019: lot 166592: (b)(4) items manufactured and released on 07 march 2017.Expiration date: 2022-02-21.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 had a total hip replacement (b)(6) 2017 which had to be revised on the (b)(6) 2017 due to fracture (no implants has been removed).The patient then suffered from an infection which resulted in all implants needed to be extracted ((b)(6) 2018).On (b)(6) 2019 all implants were removed due to infection, pathogen unknown.

• Brand Name: QUADRA-C CEMENTED, MIRROR POLISHING STD STEM SIZE 1 12/14
• Common Device Name: CEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8835298
• Report Number: 3005180920-2019-00656
• Device Sequence Number: 2743035
• Product Code: LZO
• UDI-Device Identifier: 07630030802225
• UDI-Public: 07630030802225
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2019

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: 09/20/2021
• Device Catalogue Number: 01.12.041
• Device Lot Number: 164578
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 07/29/2019
• 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: 77 YR