MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø50 MULTI-HOLE; HIP SHELL CEMENTLESS

Catalog Number	01.32.150MH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 november 2018: lot 163607: (b)(4) items manufactured and released on 15-sep-2016.Expiration date: 2021-08-31.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: liner: mpact 01.32.3241hct flat pe hc liner ø32/d, lot 177246: (b)(4) items manufactured and released on 01-mar-2018.Expiration date: 2023-02-04.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.Ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0, lot 180534: (b)(4) items manufactured and released on 12-jul-2018.Expiration date: 2023-06-26.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
About 10 days after primary surgery, the surgeon revised the patient for an infection case.Cup, liner and ball head were swapped.The surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø50 MULTI-HOLE
• Common Device Name: HIP SHELL CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8069019
• Report Number: 3005180920-2018-00908
• Device Sequence Number: 19314928
• Product Code: LPH
• UDI-Device Identifier: 07630030810770
• UDI-Public: 07630030810770
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2018

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: 08/31/2021
• Device Catalogue Number: 01.32.150MH
• Device Lot Number: 163607
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 11/14/2018
• 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