MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA COCR BALL HEAD 12/14 22 SIZE S -2,5; HIP BALL HEAD

Model Number	01.25.124
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 december 2020: lot 152708a: (b)(4) items manufactured and released on 23-jun-2010.Expiration date: 2015-06-15.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 since 2016.Additional device involved: batch review performed on 17 december 2020: liner: mpact dm 01.26.2246mhc double mobility hc liner 22.2/dmc (k092265) lot 1910310: (b)(4) items manufactured and released on 29-jun-2020.Expiration date: 2025-01-18.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
Revision surgery performed due to dislocation of the head from the liner, 2 months after primary surgery.Head and liner revised successfully.
Additional Manufacturer Narrative
Corrected data: batch review: lot 152708: 100 items manufactured and released on 26-may-2015.Expiration date: 2020-04-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.4 items were re-sterilized before the expiration date (lot 152708a), released on 01-jul-2020, expiration date: 2025-06-15.Additional device involved.Batch review: liner: mpact dm 01.26.2246mhc double mobility hc liner 22.2/dmc (k092265) lot 1910310: (b)(4) items manufactured and released on 29-jan-2020.Expiration date: 2025-01-18.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.Additional info: pieces returned 12 feb 2020.Visual inspection performed by medacta hip r&d project manager: visual inspection performed on 18th february 2021.From the received pieces, the head and liner did not show any particular sign of damage related to the event.In particular, the diameter of the retentive part of the liner seemed not to be worn or ovalized, or with other defects that could have caused the dislocation of the ball head.Also for the head, no particular signs on the surface were noticed.The pieces were analysed and the diameter dimensions of liner and head resulted conform.From the performed analysis, the root cause of the event is unknown, but a possible reason can be related to a lock of the liner to an anatomic portion and a subsequent lever of the neck stem that caused the dislocation of the ball head from the liner.

• Brand Name: COCR BALL HEAD 12/14 22 SIZE S -2,5
• Common Device Name: HIP BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11106972
• Report Number: 3005180920-2021-00002
• Device Sequence Number: 3596025
• Product Code: JDI
• UDI-Device Identifier: 07630030805486
• UDI-Public: 07630030805486
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K080885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2021

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: 04/30/2020
• Device Model Number: 01.25.124
• Device Catalogue Number: 01.25.124
• Device Lot Number: 152708A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2020
• Supplement Date Received by Manufacturer: 12/05/2020
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 02/19/2021
• 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
• Patient Age: 76 YR