MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SHELL Ø54 TWO-HOLES; CEMENTLESS ACETABULAR SHELL

Catalog Number	01.32.154DH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 october 2017.Lot 168442: (b)(4) items manufactured and released on 01 march 2017.Expiration date: 2022-02-20.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.Masterloc cementless ti coated stem size 9 lat, code 01.39.209, lot.156738 (k151531) (b)(4) items manufactured and released on 18 march 2016.Expiration date: 2021-03-07.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Mpact flat pe hc liner ø36/e, code 01.32.3644hct, lot.168470 (k103721) lot 168470: (b)(4) items manufactured and released on 08 march 2017.Expiration date: 2022-02-13.No anomalies found related to the reported issue.To date, (b)(4) items of the same lot have been already sold and this is the second similar event reported on the lot.Mectacer biolox delta ceramic ball head 12/14 ø 36 size m 0, code 01.29.209, lot.170697 (k112115) lot 170697: (b)(4) items manufactured and released on 30 may 2017.Expiration date: 2022-05-11.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.Mpact cancellous bone screw, flat head ø 6,5 l 25, code 01.32.6525, lot.170647 (k103721) lot 170647: (b)(4) items manufactured and released on 13 march 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.
Event or Problem Description
The patient came in due to signs of infection.The pathogen is unknown.The surgeon revised all medacta hardware and implanted a spacer.The surgery was completed successfully.

• Brand Name: MPACT ACETABULAR SHELL Ø54 TWO-HOLES
• Common Device Name: CEMENTLESS ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6979324
• Report Number: 3005180920-2017-00613
• Device Sequence Number: 10873657
• Product Code: LPH
• UDI-Device Identifier: 07630030810824
• UDI-Public: 07630030810824
• Combination Product (Y/N): N
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2017

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: 02/20/2022
• Device Catalogue Number: 01.32.154DH
• Device Lot Number: 168442
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 10/26/2017
• 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