MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SCREWS: MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 35

Model Number	01.32.6535
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 january 2020: lot 1706505: (b)(4) items manufactured and released on 16-mar-2017.Expiration date: 2022-03-05.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 items involved in the event, batch review performed on 07 january 2020.Screws: mpact 01.32.6525 cancellous bone screw, flat head 6,5 l 25 (k103721) lot.167232 lot 167232: (b)(4) items manufactured and released on 05-dec-2016.Expiration date: 2021-11-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event.Screws: mpact 01.32.6535 cancellous bone screw, flat head 6,5 l 35 (k103721) lot.168797 lot 168797: (b)(4) items manufactured and released on 06-feb-2017.Expiration date: 2022-01-25.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.Cup: mpact 01.32.156mh acetabular shell 56 multi-hole (k1328799) lot.173224 lot 173224: (b)(4) items manufactured and released on 01-sep-2017.Expiration date: 2022-08-18.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.Liner: mpact 01.32.3648hct flat pe hc liner 36/f (k103721) lot.171741 lot 171741: (b)(4) items manufactured and released on 27-sep-2017.Expiration date: 2022-09-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event.Ball heads: cocr 01.25.034 cocr ball head 12/14 36 size xxl +10.5 (k080885) lot.162376 lot 162376: (b)(4) items manufactured and released on 26-jul-2016.Expiration date: 2021-07-10.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.Stem: amistem h 01.18.133 ha coated std stem #3 (k093944) lot.165812 lot 165812: (b)(4) items manufactured and released on 05-jan-2017.Expiration date: 2021-12-14.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.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all hardware and implanted an antibiotic spacer 1 year and 11 months after primary.The surgery was completed successfully.

• Brand Name: SCREWS: MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 35
• Common Device Name: CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 35
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9646641
• Report Number: 3005180920-2020-00010
• Device Sequence Number: 19533143
• Product Code: LPH
• UDI-Device Identifier: 07630030812408
• UDI-Public: 07630030812408
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/30/2020

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: 03/05/2022
• Device Model Number: 01.32.6535
• Device Catalogue Number: 01.32.6535
• Device Lot Number: 170650
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2020
• Initial Report FDA Received Date: 01/30/2020
• 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