MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: COCR BALL HEAD 12/14 Ø 36 SIZE S -3.5; HIP METAL FEMORAL HEAD

Model Number	01.25.030
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Osteolysis (2377)
Date of Event	04/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02-may-2023.Lot 151916: (b)(4) items manufactured and released on 11-sep-2015.Expiration date: 2020-07-31.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported case during the period of review.Stem: amistem h 01.18.134 ha coated std stem size 4 (k093944) lot.155658: (b)(4) items manufactured and released on 09-feb-2016.Expiration date: 2021-01-27.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by medica affairs department revision surgery 6 years and 11 months after primary tha due to osteolysis possibly related to suspected trunnionosis from the cocr head metal taper in the proximal femur and around the cup implant.However, the pictures that were examined did not show macroscopic damages to the head that would be compatible with such diffuse osteolysis.From radiographic images, a greater trochanter fracture is visible, probably related to osteolytic consequenses.The surgeon revised successfully cup, head and liner.Preliminary investigation performed by r&d project manager from the description and from the pictures received it is not possible to establish a root cause.From the pictures we can see that the cocr 01.25.030 cocr ball head 12/14 ø 36 size s -3.5 lot.151916 sems to have some signs /scratches in the inner part of the conical connection but the images are not sufficient clear.The images not show macroscopic damages to the head that would be compatible with such diffuse osteolysis mentioned in the event description.It is not possible to determine a root cause of these scratches since they could potentially have been caused both from the possible ware between the stem taper and the femoral head connection and during the head removal phase.We will try to better understand from the visual inspection once the specimens will be available.
Event or Problem Description
Revision surgery performed at about 6 years and 11 months after primary due to suspected trunnionosis from the cocr head metal taper and osteolysis in the proximal femur and around the cup implant.Moreover, x-rays show a greater trochanter fracture.The surgeon revised successfully cup, head and liner.
Additional Manufacturer Narrative
Correction of data reported: - despite the initial communication, the devices were not available.

• Brand Name: BALL HEADS: COCR BALL HEAD 12/14 Ø 36 SIZE S -3.5
• Common Device Name: HIP METAL FEMORAL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16970519
• Report Number: 3005180920-2023-00371
• Device Sequence Number: 5225659
• Product Code: JDI
• UDI-Device Identifier: 07630030805202
• UDI-Public: 07630030805202
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K080885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2023

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: 07/31/2020
• Device Model Number: 01.25.030
• Device Catalogue Number: 01.25.030
• Device Lot Number: 151916
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 05/20/2023
• Supplement Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 100 KG