MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: COCR BALL HEAD 12/14 Ø 32 SIZE M 0; METAL FEMORAL BALL HEAD

Catalog Number	01.25.022
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs manager: hip dislocation few days after primary implantation.According to the report, this event occurred while moving in bed.Hip dislocation may be due to component positioning or insufficient soft tissue tensioning; it can hardly be caused by standard devices.Visual inspection performed by r&d project manager: revision due to primary mobilization.Implant almost intact as new.No-implant related failure root cause.Batch review performed on 08 april 2019: lot 186282: (b)(4) items manufactured and released on 19-dec-2018.Expiration date: 2023-12-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional components involved: stem: amistem h 01.18.173 amistem-h proximal coating std stem size 3 (k161635), lot 184654: (b)(4) items manufactured and released on 07-nov-2018.Expiration date: 2023-10-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Liner: cc e cc light 01.26.3244hct flat pe hc liner ø 32 / e (k103352), lot 187111: (b)(4) items manufactured and released on 08-nov-2018.Expiration date: 2023-10-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
Three weeks after primary surgery, the patient moved in bed so there was a luxation of the hip.The head dislocated from the liner.In addition to the luxation, the stem got turned/rotated.The stem was replaced by an amistem-c.Head was replaced as well.Primary surgery was in amis.The bone quality was not so good, in particular on the proximal part.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager: revision due to primary mobilization.Implant almost intact as new.No-implant related failure root cause.

• Brand Name: BALL HEADS: COCR BALL HEAD 12/14 Ø 32 SIZE M 0
• Common Device Name: METAL FEMORAL BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8503595
• Report Number: 3005180920-2019-00273
• Device Sequence Number: 13914955
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2019

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: 12/09/2023
• Device Catalogue Number: 01.25.022
• Device Lot Number: 186282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2019
• Supplement Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 04/25/2019
• 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: 62 YR
• Patient Weight: 82