MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: COCR COCR BALL HEAD 12/14 28 SIZE XL +7; METAL BALL HEAD

Model Number	01.25.014
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 august 2021: lot 130914: (b)(4) items manufactured and released on 03-june-2013.Expiration date: 2018-04-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event on this lot since 2017.Additional implant involved: liner: versafitcup dm 01.26.2854mhc double mobility hc liner 28/dmg (k092265) lot.152102.Batch review performed on 23 august 2021: lot 152102: (b)(4) items manufactured and released on 20-aug-2015.Expiration date: 2020-06-30.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event since 2017.Additional implant involved: stem: amistem h 01.18.133 ha coated std stem size 3 (k093944) lot.154485.Batch review performed on 23 august 2021.Lot 154485: (b)(4) items manufactured and released on 06-nov-2015.Expiration date: 2020-10-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event on this lot since 2017.
Event or Problem Description
5 years and 7 months after the primary the patient came in reporting instability due to a leg length discrepancy and the cause of the leg length discrepancy is unknown.The surgeon revised the stem and head with competitor components and revised the medacta liner with a medacta liner.The surgery was completed successfully.

• Brand Name: BALL HEADS: COCR COCR BALL HEAD 12/14 28 SIZE XL +7
• Common Device Name: METAL BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12466363
• Report Number: 3005180920-2021-00735
• Device Sequence Number: 20018312
• Product Code: JDI
• UDI-Device Identifier: 07630030805134
• UDI-Public: 07630030805134
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2021

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: 04/30/2018
• Device Model Number: 01.25.014
• Device Catalogue Number: 01.25.014
• Device Lot Number: 130914
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 09/14/2021
• 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