MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 28; HIP CERAMIC BALL HEAD

Model Number	01.29.230H
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in for a primary hip surgery on (b)(6) 2022.On (b)(6) 2022, the patient came in reporting pain due to a dislocation of the head from the liner and the cause was unknown.The surgeon revised the head and liner and surgery was completed successfully.Presently, on (b)(6) 2022, the patient came in reporting pain due to a dislocation of the head from the liner and the cause is unknown.The surgeon revised the head and liner and surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 03 november 2022.Lot 2105998: (b)(4) items manufactured and released on 16-sep-2021.Expiration date: 2026-09-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs department: two months after partial revision of a recent tha, the patient suffers an intraprosthetic dislocation: the femoral head dislocates from the retentive double-mobility liner, according to report.The fact is most unusual, particularly because the same problem had happened one month after primary surgery.The explanted evices have not been sent back to manufacturer for dimensional check.We have no knowledge of a former previous case with this sequence of events, with a 28mm head.No clinical cause could be identified or hypothesized.Additional implant involved.Batch review performed on 03 november 2022 on liner: versafitcup dm 01.26.2848mhc double mobility hc liner ø 48/28 (k092265) lot.2113063 lot 2113063: (b)(4) items manufactured and released on 09-nov-2021.Expiration date: 2026-10-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 28
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15885751
• Report Number: 3005180920-2022-00876
• Device Sequence Number: 4965464
• Product Code: LZO
• UDI-Device Identifier: 07630030809323
• UDI-Public: 07630030809323
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K131518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 11/30/2022

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: 09/01/2026
• Device Model Number: 01.29.230H
• Device Catalogue Number: 01.29.230H
• Device Lot Number: 2105998
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2021
• 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: Unknown