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

Catalog Number	01.32.156DH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 november 2018: lot 161068: (b)(4) items manufactured and released on 29-aug-2016.Expiration date: 2021-08-17.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 components revised: stem: masterloc 01.39.205 cementless ti coated lat stem size 5 (k151531), lot 162207: (b)(4) items manufactured and released on 24 june 2016.Expiration date: 2021-06-14.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.Screws: mpact 01.32.6540 cancellous bone screw, flat head ø 6,5 l 40 (k103721), lot 168800: (b)(4) items manufactured and released on 15 february 2017.Expiration date: 2022-02-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without 1 similar reported event.Liner: mpact 01.32.3648hct flat pe hc liner ø36/f (k103721), lot 168473: (b)(4) items manufactured and released on 07 march 2017.Expiration date: 2022-02-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with 1 similar reported event.Ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115), lot 164224: (b)(4) items manufactured and released on 13 october 2016.Expiration date: 2021-10-02.No anomalies found related to the issue.To date, all items of the same lot have been already sold with 2 similar reported events.Mpact 01.31.55tp shell screw plug (k103721), lot 160676: (b)(4) items manufactured and released on 26 february 2016.Expiration date: 2021-01-25.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 after about 1 year and 3 months due to signs of infection.The pathogen is unknown at this time.The surgeon removed all hardware and implanted a spacer.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø56 TWO-HOLES
• Common Device Name: CEMENTLESS HIP SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8105806
• Report Number: 3005180920-2018-00950
• Device Sequence Number: 1900190
• 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: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/27/2018

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: 08/17/2021
• Device Catalogue Number: 01.32.156DH
• Device Lot Number: 161068
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 11/27/2018
• 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