MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø52 MULTI-HOLE; HIP ACETABULAR SHELL

Model Number	01.32.152MH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed 2 years and 8 months due to infection.All implants removed and spacer implanted.
Additional Manufacturer Narrative
Batch review performed on 21 january 2022.Lot 185415: (b)(4) items manufactured and released on 09-oct-2018.Expiration date: 2023-sep-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Clinical evaluation performed by medical affairs manager: late infection in cemented tha, 3 years after primary operation.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices additional items involved in the event, batch review performed on 21 january 2022: liner: mpact 01.32.3644 hct flat pe hc liner ø36/e (k103721) lot.188901, lot 188901: (b)(4) items manufactured and released on 10-dec-2018.Expiration date: 2023-nov-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Mectaplug 01.33.102 mectaplug pe size 2 lot.188261 (item not registered in usa).Lot 188261: (b)(4) items manufactured and released on 20-dec-2018.Expiration date: 2023-dec-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Stem: quadra-c 01.12.043 cemented, mirror polishing std stem size 3 12/14 (k083558) lot.184785 lot 184785: (b)(4) items manufactured and released on 27-sep-2018.Expiration date: 2023-sep-16.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event.Ball heads: cocr 01.25.031 cocr ball head 12/14 ø 36 size m 0 (k080885) lot.182513.Lot 182513: (b)(4) items manufactured and released on 05-jul-2018.Expiration date: 2023-jun-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.
Additional Manufacturer Narrative
On 8 april 2022 we noticed that there was an error on the batch review of the liner: impact 01.32.3644hct flat pe hc liner ø36/e (k103721) lot.188901.Corrected batch review: batch review performed on 21 january 2022.Lot 188901: 110 items manufactured and released on 10-dec-2018.Expiration date: 2023-nov-16.No anomalies found related to the problem.To date, 109 items of the same lot have been sold with two similar reported events.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø52 MULTI-HOLE
• Common Device Name: HIP ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13548449
• Report Number: 3005180920-2022-00110
• Device Sequence Number: 5199397
• Product Code: LPH
• UDI-Device Identifier: 07630030810800
• UDI-Public: 07630030810800
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2022

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: 09/30/2023
• Device Model Number: 01.32.152MH
• Device Catalogue Number: 01.32.152MH
• Device Lot Number: 185415
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Race: White