MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SHELL Ø 58 TWO-HOLES; CEMENTLESS ACETABULAR SHELL

Catalog Number	01.32.158DH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch reviews performed on 18 september 2017.Lot 164345: (b)(4) items manufactured and released on 29 august 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.Amistem collared stem, ha coated stem size 7 std, code 01.18.237, lot.153454 (k121011) (b)(4) items manufactured and released on 11 september 2015.Expiration date: 2020-08-23.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.Mectacer biolox delta ceramic ball head 12/14 ø 40 size l + 4, code 01.29.214, lot.141174 (k112115) (b)(4) items manufactured and released on 02 june 2014.Expiration date: 2019-04-30.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 flat pe hc liner ø40/f, code 01.32.4048hct, lot.162090 (k122641) (b)(4) items manufactured and released on 01 july 2016.Expiration date: 2021-06-12.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.Mpact shell screw plug, code 01.31.55tp, lot.165385 (k103721) (b)(4) items manufactured and released on 08 august 2016.Expiration date: 2021-07-26.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.Mpact cancellous bone screw, flat head ø 6,5 l 40, code 01.32.6540, lot.165279 (k103721) (b)(4) items manufactured and released on 12 september 2016.Expiration date: 2021-08-22.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 removed all medacta hardware.The surgeon implanted a spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
On (b)(6) 2017 it was communicated the following: on (b)(6) 2017 the spacer was revised and the following permanent implants were put into the patient.

• Brand Name: MPACT ACETABULAR SHELL Ø 58 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: 6878299
• Report Number: 3005180920-2017-00521
• Device Sequence Number: 761501
• 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: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2017

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: 08/17/2021
• Device Catalogue Number: 01.32.158DH
• Device Lot Number: 164345
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/22/2017
• Supplement Date Received by Manufacturer: 08/22/2017
• Initial Report FDA Received Date: 09/20/2017
• Supplement Report FDA Received Date: 12/22/2017
• 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
• Patient Age: 62 YR