MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL 52 TWO-HOLES; ACETABULAR CUP

Model Number	01.32.152DH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 september 2020: lot 172585: (b)(4) items manufactured and released on 03-oct-2017.Expiration date: 2022-09-24.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 implant involved: liner: mpact 01.32.3244hcat hooded pe hc liner ø32/e (k132879) lot.160915.Batch review performed on 08 september 2020: lot 160915: (b)(4) items manufactured and released on 22-mar-2016.Expiration date: 2021-03-08.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.Additional implant involved: ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115) lot.173291.Batch review performed on 08 september 2020: lot 173291: (b)(4) items manufactured and released on 07-sep-2017.Expiration date: 2022-08-27.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 implant involved: stem: quadra-h 01.12.23sn cementless, ha coated std stem size 3, short neck (k082792) lot.163273.Batch review performed on 08 september 2020: lot 163273: (b)(4) items manufactured and released on 12-aug-2016.Expiration date: 2021-07-26.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
Revision surgery performed, 1 month after primary surgery, due to infection.Right side.

• Brand Name: CUP: MPACT ACETABULAR SHELL 52 TWO-HOLES
• Common Device Name: ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10612281
• Report Number: 3005180920-2020-00662
• Device Sequence Number: 2729955
• Product Code: LPH
• UDI-Device Identifier: 07630030810794
• UDI-Public: 07630030810794
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/01/2020

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: 09/24/2022
• Device Model Number: 01.32.152DH
• Device Catalogue Number: 01.32.152DH
• Device Lot Number: 172585
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 10/01/2020
• 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
• Patient Age: 59 YR
• Patient Weight: 133