MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT 3DMETAL ACETABULAR SHELL Ø50 TWO-HOLE

Catalog Number	01.38.050DH
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 7 january 2020: lot 1810872: (b)(4) items manufactured and released on 28-jan-2019.Expiration date: 2024-01-16.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 items involved in the event, batch review performed on 7 january 2020: liner: mpact 01.32.3241hct flat pe hc liner ø32/d (k103721) lot.1903446.Lot 1903446: (b)(4) items manufactured and released on 21-mar-2019.Expiration date: 2024-05-08.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.Liner: mpact 01.32.3241hct flat pe hc liner ø32/d (k103721) lot.1901462.Lot 1901462: (b)(4) items manufactured and released on 25-apr-2019.Expiration date: 2024-04-13.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
During the primary hip surgery, the surgeon attempted to insert an mpact flat liner hc 32/d into the mpact 3d metal shell two hole 50mm, but it would not seat.The surgeon explanted the liner and attempted to insert a different mpact flat liner hc 32/d but it would not seat into the cup.The surgeon explanted the liner, cup and screws and reamed the acetabulum up one size.He then implanted an mpact 3d metal shell two hole 52mm, mpact flat liner hc 36/e and screws with no further issues.There was a 25-minute delay in the case and the surgery was completed successfully.The surgeon had to ream the acetabulum up one size and the patient was under additional anesthesia.
Additional Manufacturer Narrative
Additional considerations after the cq analysis (23rd march 2020): the acetabular shell revealed to be correctly dimensioned according to the specifications, while some dimensions of the liner was slightly out of tolerance; this is most probably due to the deformation of the hc pe after the use and sterilization.For these reasons, we can conclude that the most probable root cause of the event is related to a possible third body inside the shell that prevented the correct insertion of the liner.
Event or Problem Description
During the primary hip surgery, the surgeon attempted to insert an impact flat liner hc 32/d into the impact 3d metal shell two hole 50mm, but it would not seat.The surgeon explanted the liner and attempted to insert a different impact flat liner hc 32/d but it would not seat into the cup.The surgeon explanted the liner, cup and screws and reamed the acetabulum up one size.He then implanted an impact 3d metal shell two hole 52mm, mpact flat liner hc 36/e and screws with no further issues.There was a 25-minute delay in the case and the surgery was completed successfully.The sales representative reported that he was able to couple the insert and the cup (after receiving the cup and the liner were coupled).Probably something blocked the liner during the surgery to seat correctly in the cup.
Additional Manufacturer Narrative
During the primary hip surgery, the surgeon attempted to insert an impact flat liner hc 32/d into the impact 3d metal shell two hole 50mm, but it would not seat.The surgeon explanted the liner and attempted to insert a different impact flat liner hc 32/d but it would not seat into the cup.The surgeon explanted the liner, cup and screws and reamed the acetabulum up one size.He then implanted an impact 3d metal shell two hole 52mm, impact flat liner hc 36/e and screws with no further issues.There was a 25-minute delay in the case and the surgery was completed successfully.The sales representative reported that he was able to couple the insert and the cup (after receiving the cup and the liner were coupled).Probably something blocked the liner during the surgery to seat correctly in the cup.Visual inspection performed by medacta hip r&d project manager: visual inspection performed on (b)(6) 2020.From the received pieces it was not possible to determine the root cause of the event.Probably, the event was related to a body in the bottom of the external shell, not completely cleaned before the assembly, that caused the failure of the coupling.

• Brand Name: CUP: MPACT 3DMETAL ACETABULAR SHELL Ø50 TWO-HOLE
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9575259
• Report Number: 3005180920-2019-01125
• Device Sequence Number: 2423119
• Product Code: LPH
• UDI-Device Identifier: 07630030812583
• UDI-Public: 07630030812583
• 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,Followup,Followup
• Report Date (Section B): 04/07/2020

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: 01/16/2024
• Device Catalogue Number: 01.38.050DH
• Device Lot Number: 1810872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 12/11/2019; 12/11/2019
• Initial Report FDA Received Date: 01/10/2020
• Supplement Report FDA Received Date: 03/17/2020; 04/07/2020
• 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: Other