MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE XL +

Model Number 01.29.211

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Muscle Weakness (1967); Unequal Limb Length (4534)

Event Date 01/05/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 8 january 2021: lot 187092: (b)(4) items manufactured and released on 19-dec-2018.Expiration date: 2023-12-05.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.Clinical evaluation performed by medical affairs director: 1,5 years after primary cementless tha the complex, affected by scoliosis and other musculoskeletal disorders, requests that his leg be made longer, and therefore the head is exchanged to a longer one.The reason for this reoperation is not linked in any way to a defective device.

Event Description

The patient had returned for a second revision after 1 year and 5 months from the previous revision, due to complicated musculoskeletal condition that resulted in him feeling shorter on the left side despite the previous revision to a size +8 head.The patient has complex scoliosis and neural cord damage causing subsequent muscle weakness.The leg length and offset on xr and examination of the patient are satisfactory, however, the patient preferred for the leg to be made longer.The operation was again via a bikini incision anterior approach.The ceramic head was removed and a competitor head and sleeve were implanted.

• Brand Name: BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE XL +
• Type of Device: CERAMIC BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 11271949
• MDR Text Key: 230027270
• Report Number: 3005180920-2021-00078
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030809224
• UDI-Public: 07630030809224
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K112115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/03/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2023
• Device Model Number: 01.29.211
• Device Catalogue Number: 01.29.211
• Device Lot Number: 187092
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 02/03/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention