MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SHELL Ø50 TWO-HOLES

Catalog Number	01.32.150DH
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Disorder (2373)
Date of Event	04/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 may2018.Lot 166604: 78 items manufactured and released on 20 january 2017.Expiration date: 2022-01-11.No anomalies found related to the problem.To date, 74 items of the same lot have been already sold without any similar reported event.Others devices involved: amistem collared stem collared ha coated std stem size 2 reference (b)(4).Lot 166466: 100 items manufactured and released on 11 january 2017.Expiration date: 2022-01-03.No anomalies found related to the problem.To date, 93 items of the same lot have been already sold without any similar reported event.Mpact cancellous bone screw, flat head ø 6,5 l 40 ,reference (b)(4).Lot 168800: 130 items manufactured and released on 15 february 2017.Expiration date: 2022-02-02.No anomalies found related to the problem.To date, 78 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 reference (b)(4).Lot 168792: 169 items manufactured and released on 06 february 2017.Expiration date: 2022-01-25.No anomalies found related to the problem.To date, 144 items of the same lot have been already sold without any similar reported event.Mectacer biolox delta ceramic ball head 12/14 ø 32 size l +4 reference (b)(4).Lot 162726: 80 items manufactured and released on 27 july 2016.Expiration date: 2021-07-19 no anomalies found related to the problem.To date, 59 items of the same lot have been already sold without any similar reported event.Mpact shell screw plug reference (b)(4).Lot 168461: 120 items manufactured and released on 16 december 2016.Expiration date: 2021-12-06.No anomalies found related to the problem.To date, 99 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 about 1 year after primary.The patient also had a loose stem.It is unknown if the potential infection caused the loosening.The surgeon revised all hardware and implanted a spacer.The surgery was completed successfully.Pathogen involved is staphylococcus epidermidis.
Additional Manufacturer Narrative
Update received on 07 august 2018: on (b)(6) 2018 the surgeon removed the spacer and implanted another spacer as the infection has not subsided.The infection has been confirmed as staph epi.The surgery was completed successfully.

• Brand Name: MPACT ACETABULAR SHELL Ø50 TWO-HOLES
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7514386
• Report Number: 3005180920-2018-00327
• Device Sequence Number: 19335726
• Product Code: LPH
• UDI-Device Identifier: 07630030810763
• UDI-Public: 07630030810763
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2018

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: 01/11/2022
• Device Catalogue Number: 01.32.150DH
• Device Lot Number: 166604
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2018
• Supplement Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 09/05/2018
• 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