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
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Unequal Limb Length (4534)
Date of Event	01/05/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 +
• Common Device Name: CERAMIC BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11271949
• Report Number: 3005180920-2021-00078
• Device Sequence Number: 3842781
• Product Code: LZO
• UDI-Device Identifier: 07630030809224
• UDI-Public: 07630030809224
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K112115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 02/03/2021
• 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