MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M; HIP CERAMIC BALL HEAD

Catalog Number	01.29.205
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Joint Dislocation (2374); Inadequate Osseointegration (2646)
Date of Event	05/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Hip revision at about 1 month post primary.Dislocation of the head from the liner and the cup moved from the acetabulum.The patient did not follow the surgeon's recommendations because he had no pain and moved without canes directly after surgery.No loosening of the stem.No infection.Acetabular components and femoral head revised successfully.
Additional Manufacturer Narrative
Batch review performed on 27 june 2024.Lot 2405084: (b)(4) manufactured and released on 15-mar-2024.Expiration date: 2029-02-27.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs department a revision surgery was performed one month after the primary tha due to a dislocation.The patient was reported to be non-compliant with the surgeon's recommendations, moving without canes.In addition, the surgeon suspected a falling episode or an inappropriate hip movement.The available pre revision x-ray images show a tilted acetabular component with inadequate version, possibly resulting from the dislocation (and subsequent reduction).Dislocation is a known complication after a tha.Possible causes include falling or improper hip movements, as suspected in this case.We have no reason to suspect a defective or malfunctioning device.Additional revised implants batch review performed on 27 june 2024 on liner: mectacer 01.29.411 ceramic liner ø 32 / f lot.2315577 lot 2315577: (b)(4) manufactured and released on 30-jun-2023.Expiration date: 2028-06-11.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.Product not marketed in us.Batch review performed on 11 june 2024 on cup: versafitcup cc trio 01.26.45.0056 acetabular shell cc trio ø 56 (k103352) lot.2312674 lot 2312674: (b)(4) manufactured and released on 12-oct-2023.Expiration date: 2028-09-18.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M
• Common Device Name: HIP CERAMIC BALL 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: 19623415
• Report Number: 3005180920-2024-00479
• Device Sequence Number: 8084904
• Product Code: LZO
• UDI-Device Identifier: 07630030809163
• UDI-Public: 07630030809163
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K112115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 06/27/2024

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 Catalogue Number: 01.29.205
• Device Lot Number: 2405084
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2024
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 110 KG