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

Catalog Number	01.32.158DH
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Disorder (2373)
Date of Event	01/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 february 2018 lot 165901: (b)(4) items manufactured and released on 16 december 2016.Expiration date: 2021-12-04 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.Flat pe hc liner ø36/f reference 01.32.3648hct (k103721) lot 171741: (b)(4) items manufactured and released on 23 september 2017.Expiration date: 2022-09-03 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 h ha coated std stem size 7 reference 01.18.137 (k093944) lot 141474: (b)(4) items manufactured and released on 08 july 2014.Expiration date: 2019-05-31 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.Mectacer biolox delta ceramic ball head 12/14 ø 36 size l + 4 reference 01.29.210 (k112115) lot 162735: (b)(4) items manufactured and released on 27 july 2016.Expiration date: 2021-07-19 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 complaining of pain.Due to this sign of possible infection (pathogen unknown), the surgeon removed all components and implanted a spacer.In addition to the infection, the patient had dislocated.

• Brand Name: MPACT ACETABULAR SHELL Ø58 TWO-HOLES
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7306122
• Report Number: 3005180920-2018-00104
• Device Sequence Number: 957464
• Product Code: LPH
• UDI-Device Identifier: 07630030810893
• UDI-Public: 07630030810893
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/01/2018

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: 12/04/2021
• Device Catalogue Number: 01.32.158DH
• Device Lot Number: 165901
• 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: 01/30/2018
• Initial Report FDA Received Date: 03/01/2018
• 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