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

Catalog Number	01.32.156DH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 august 2019: lot 172587: (b)(4) items manufactured and released on 17-oct-2017.Expiration date: 2022-10-05.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.Additional implants involved: liner: mpact 01.32.3648hct flat pe hc liner ø36/f (k103721), lot.174525.Batch review performed on 20 august 2019: lot 174525: (b)(4) items manufactured and released on 15-dec-2017.Expiration date: 2022-11-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional implants involved: screws: mpact 01.32.6530 cancellous bone screw, flat head ø 6,5 l 30 (k103721), lot.175082.Batch review performed on 20 august 2019: lot 175082: (b)(4) items manufactured and released on 11-oct-2017.Expiration date: 2022-10-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional implants involved: screws: mpact 01.32.6520 cancellous bone screw, flat head ø 6,5 l 20 (k103721), lot.175731.Batch review performed on 20 august 2019: lot 175731: (b)(4) items manufactured and released on 09-jan-2018.Expiration date: 2022-10-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional implants involved: stem: amistem h 01.18.133 ha coated std stem size 3 (k093944), lot.175917.Batch review performed on 20 august 2019: lot 175917: (b)(4) items manufactured and released on 07-feb-2018.Expiration date: 2023-01-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional implants involved: ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115), lot.174721.Batch review performed on 20 august 2019: lot 174721: (b)(4) items manufactured and released on 22-nov-2017.Expiration date: 2022-11-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.On (b)(6) 2019 we were informed that the surgeon would have removed all hardware and implanted an antibiotic spacer on (b)(6) 2019 (1 year and 5 months after primary).The surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø56 TWO-HOLES
• Common Device Name: ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8953726
• Report Number: 3005180920-2019-00744
• Device Sequence Number: 13963476
• 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
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2019

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: 10/05/2022
• Device Catalogue Number: 01.32.156DH
• Device Lot Number: 172587
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 09/02/2019
• 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: Required Intervention