MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA COCR BALL HEAD 12/14 Ø 28 SIZE S -3.5

Catalog Number	01.25.011
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 june 2018.Lot 174664: items manufactured and released on 22 november 2017.Expiration date: 2022-11-13.No anomalies found related to the problem.To date, 79 items of the same lot have been already sold without any similar reported event.Other devices involved amistem h 01.18.232(k121011), stem collared ha coated std stem #2 l.Lot 172623: 47 items manufactured and released on 28 august 2017.Expiration date: 2022-08-17 no anomalies found related to the problem.To date, 43 items of the same lot have been already sold without any similar reported event.Mpact double mobility hc liner 28/dmh reference (b)(4).Lot 174325: 40 items manufactured and released on 27 november 2017.Expiration date: 2022-11-14.No anomalies found related to the problem.To date, 20 items of the same lot have been already sold without any similar reported event.Mpact double mobility acetabular shell ø56 reference (b)(4).Lot 176090: 40 items manufactured and released on 27 november 2017.Expiration date: 2023-01-09.No anomalies found related to the problem.To date, 16 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
About 3 months after primary the surgeon revised the patient for hip pain.The reason of pain is unknown, all the implants were swapped successfully.

• Brand Name: COCR BALL HEAD 12/14 Ø 28 SIZE S -3.5
• Common Device Name: COCR BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7637642
• Report Number: 3005180920-2018-00463
• Device Sequence Number: 16532844
• Product Code: JDI
• UDI-Device Identifier: 07630030805103
• UDI-Public: 07630030805103
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2018

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: 11/13/2022
• Device Catalogue Number: 01.25.011
• Device Lot Number: 174664
• 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: 05/31/2018
• Initial Report FDA Received Date: 06/26/2018
• 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
• Patient Age: 41 YR