MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA COCR BALL HEAD 12/14 32 SIZE M 0; HIP METALLIC BALL HEAD

Model Number	01.25.022
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 october 2021: lot 2012862: (b)(4) items manufactured and released on 30-03-2021.Expiration date: 2026-03-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without a similar reported event.Additional device involved: batch review performed on 08 october 2021: liner: versafitcup cc trio 01.26.3244hct flat pe hc liner ø 32 / e (k103352) lot 2100167: (b)(4) items manufactured and released on 4-03-2021.Expiration date: 2026-02-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without a similar reported event.
Event or Problem Description
About 3 weeks after the primary surgery the surgeon revised the head and liner due to dislocation (head-liner) after the physiotherapy.

• Brand Name: COCR BALL HEAD 12/14 32 SIZE M 0
• Common Device Name: HIP METALLIC BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12688360
• Report Number: 3005180920-2021-00840
• Device Sequence Number: 19836595
• Product Code: JDI
• UDI-Device Identifier: 07630030805165
• UDI-Public: 07630030805165
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2021

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: 03/17/2026
• Device Model Number: 01.25.022
• Device Catalogue Number: 01.25.022
• Device Lot Number: 2012862
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 10/25/2021
• 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: 79 YR
• Patient Weight: 85