MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø56 TWO-HOLES; HIP ACETABULAR UNCEMENTED SHELL

Catalog Number	01.32.156DH
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 june 2019: lot 178417: (b)(4) items manufactured and released on 03 april 2018.Expiration date: 2023-03-22.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.Additional device involved: amis 01.15.10.0636 amis cup impactor 3.0-m8 (hpf) lot.1855199.Supplier manufacturing batch review on the 01.15.10.0636: batch released on date: 24/10/2018 n.Of pieces released: (b)(4).All the steps, according to our routing sheet and relative drawings, have been performed correctly as well as the dimensional and functional controls.Other complaints already received on this batch.There aren't non conformity elements in the document review.Sales representative reported as follows on jun 21st 2019: i don't know if the instrument thread was damaged.The same instrument was used for the second cup placement.
Event or Problem Description
During the primary hip surgery, and while using a blue offset inserter, the cup popped off the device.As the surgeon tried to thread the inserter into the cup, the threads became cross threaded.Another cup was used and the surgery was completed successfully.There was a 15 minute delay in the case.It is not known if the instrument thread was damaged.The same instrument was used for the second cup placement.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager during the analysis it is evaluated that it is not possible to screw the cup impactor with the acetabular cup.Looking at the threaded hole of the cup it is evaluable that the thread is scratched and broken.The threaded terminal of the cup impactor is little bit scratched too.It seems that the user incorrectly proceed to impact the cup before completing the screw.The instrument is ce marked by supplier.Manufacturing process review performed by the manufacturer document review batch released on date: 24/10/2018 n.Of pieces released: (b)(4).All the steps, according to our routing sheet and relative drawings, have been performed correctly as well as the dimensional and functional controls.This is the batch assigned with rework order ff18/0363.Have we received other complaint for this batch? yes.There aren't non conformity elements in the document review.
Additional Manufacturer Narrative
On july 12th 2019, we received the correct lot of the cup (186947).Batch review performed on 12 july 2019: lot 186947: (b)(4) items manufactured and released on 06 feb 2019.Expiration date: 2024-01-28.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.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø56 TWO-HOLES
• Common Device Name: HIP ACETABULAR UNCEMENTED SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8721538
• Report Number: 3005180920-2019-00503
• Device Sequence Number: 19297710
• Product Code: LPH
• UDI-Device Identifier: 07630030810855
• UDI-Public: 07630030810855
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2024
• Device Catalogue Number: 01.32.156DH
• Device Lot Number: 186947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 05/24/2019; 05/24/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 07/30/2019; 09/04/2019
• 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: Other