MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø58 TWO-HOLES; ACETABULAR SHELL CEMENTLESS

Catalog Number	01.32.158DH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 march 2019: lot 170142: (b)(4) items manufactured and released on 26-apr-2017.Expiration date: 2022-04-12.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 implants involved: stem: quadra-h 01.12.22sn cementless, ha coated std stem # 2, short neck (k082792), lot 168402: (b)(4) items manufactured and released on 12-apr-2017.Expiration date: 2022-04-02.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 170651: (b)(4) items manufactured and released on 16-mar-2017.Expiration date: 2022-03-05.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.Liner: mpact 01.32.3648hct flat pe hc liner ø36/f (k103721), lot 170980: (b)(4) items manufactured and released on 21-jun-2017.Expiration date: 2022-06-07.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 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115), lot 172268: (b)(4) items manufactured and released on 24-aug-2017.Expiration date: 2022-08-15.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 1 year and 3 months after the primary due to infection (the pathogen is unknown).The stem, the head, the liner and the cup have been revised and antibiotic spacer has been placed.The surgery was completed successfully.
Additional Manufacturer Narrative
On may 29th 2019 has been reported that on (b)(6) 2019, the patient had permanent hardware implanted.The surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø58 TWO-HOLES
• Common Device Name: ACETABULAR SHELL CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8399591
• Report Number: 3005180920-2019-00135
• Device Sequence Number: 13946932
• Product Code: LPH
• UDI-Device Identifier: 07630030810893
• UDI-Public: 07630030810893
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2019

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: 04/12/2022
• Device Catalogue Number: 01.32.158DH
• Device Lot Number: 170142
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 06/28/2019
• 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