MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER 01.29.206 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L

Model Number	01.29.206
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
After primary surgery, the patient's hip luxated two times in one week.The surgeon then decided to revise the head and the liner one week after primary.A dm converter has been implanted.An anterior approach was used during primary surgery.
Additional Manufacturer Narrative
Batch review performed on 09 february 2022.Lot 2101455: (b)(4) items manufactured and released on 27-may-2021.Expiration date: 2026-05-11.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: recurrent dislocation in primary tha requires revision one week after index surgery.The cause of dislocation, judging from the radiographs included, is to be sought in the suboptimal position of the acetabular cup.We do not know if this position has been determined by early cup migration or if it was chosen by the surgeon during primary operation for unspecified reasons.Additional implant involved: batch review performed on 09 february 2022.Liner: versafitcup cc trio 01.26.3248hct flat pe hc liner ø 32 / f (k103352) lot 2114141: (b)(4) items manufactured and released on 24-nov-2021.Expiration date: 2026-11-04.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.

• Brand Name: BALL HEADS: MECTACER 01.29.206 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L
• Common Device Name: 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: 13541837
• Report Number: 3005180920-2022-00108
• Device Sequence Number: 3734489
• Product Code: LZO
• UDI-Device Identifier: 07630030809170
• UDI-Public: 07630030809170
• 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: 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): 02/16/2022

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: 05/11/2026
• Device Model Number: 01.29.206
• Device Catalogue Number: 01.29.206
• Device Lot Number: 2101455
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2021
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White