MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER 01.29.213 MECTACER HEAD BIOLOX DELTA DIA.40 12/14-M; HIP HEAD BIOLOX DELTA

Catalog Number	01.29.213
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	04/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2020.On (b)(6) 2021, the patient came in reporting pain and instability.Post-op x-rays indicated that the stem had subsided and a physical examination revealed a leg length discrepancy of greater than 1 cm.The surgeon revised the proximal body ø20mm l 50mm lat with a 01.22.030 proximal body ø24mm l 70mm lat and revised the 40mm biolox delta head xl with a 01.29.213 40mm biolox delta head m.The surgery was completed successfully.The patient had good bone quality.The surgeon kept in the original distal stem from the primary.The distal reamer used was a size 15mm presently, on (b)(6) 2024, the patient came in reporting thigh pain and the cause is unknown.The surgeon revised the head and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 22 april 2024: lot 2002618: (b)(4) items manufactured and released on 27-july-2017.Expiration date: 2025-07-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.

• Brand Name: BALL HEADS: MECTACER 01.29.213 MECTACER HEAD BIOLOX DELTA DIA.40 12/14-M
• Common Device Name: HIP HEAD BIOLOX DELTA
• 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: 19318552
• Report Number: 3005180920-2024-00300
• Device Sequence Number: 12346851
• Product Code: LZO
• UDI-Device Identifier: 07630030809248
• UDI-Public: 07630030809248
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K112115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 05/15/2024

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 Expiration Date: 07/13/2025
• Device Catalogue Number: 01.29.213
• Device Lot Number: 2002618
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/27/2017
• 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 Sex: Female