MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT 3DMETAL 01.38.052DH ACETABULAR SHELL Ø52 TWO-HOLE; CEMENTLESS ACETABULAR SHELL

Catalog Number	01.38.052DH
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 22 february 2019: lot 153941: (b)(4) items manufactured and released on 04 april 2016.Expiration date: 2021-01-02.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 device involved in the event, ce marked by the supplier: amis 01.15.10.0538 amis cup impactor-m8 incipio lot.17j3319.The manufacturer has been informed about the event.Preliminary investigation performed by r&d project manager on the basis of the received picture: looking at the image attached to the complaint it is evaluable that the cup is blocked on the cup impactor, the lever of the cup impactor is close and it seem that the cardan screwdriver is out of its neutral position.More details will be added during the visual inspection.It is not possible to determine the root cause.The instrument is ce marked by supplier.
Event or Problem Description
During the primary hip surgery and after impacting the 52mm cup, it was discovered that the impactor handle would not disengage from the cup.The surgeon removed the original cup and implanted a different 52mm cup using a different impactor handle with no issues.There was a 5 minute delay in the case and the surgery was completed successfully.

• Brand Name: CUP: MPACT 3DMETAL 01.38.052DH ACETABULAR SHELL Ø52 TWO-HOLE
• Common Device Name: CEMENTLESS ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8361559
• Report Number: 3005180920-2019-00093
• Device Sequence Number: 1697814
• Product Code: LPH
• UDI-Device Identifier: 07630030812590
• UDI-Public: 07630030812590
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K171966
• 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
• Report Date (Section B): 02/22/2019

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: 01/02/2021
• Device Catalogue Number: 01.38.052DH
• Device Lot Number: 153941
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 02/22/2019
• 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