MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S; HIP CERAMIC BALL HEAD

Catalog Number	01.29.201
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 9 years and 3 months after primary, the patient came in reporting instability and the cause of the instability is unknown.The surgeon revised the medacta head and liner with a competitor's components and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 22-nov-2023: lot 141786: 89 items manufactured and released on 23-jun-2014.Expiration date: 2019-05-31.No anomalies found related to the problem.To date, 88 items of the same lot have been sold with no similar reported case during the period of the review.Additional device involved batch review performed on 22-nov-2023 liner: versafitcup dm 01.26.2852mhc double mobility hc liner ø52/28 (k092265) lot 143449: 33 items manufactured and released on 12-aug-2014.Expiration date: 2019-06-30.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported case during the period of the review.

• Brand Name: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18301130
• Report Number: 3005180920-2023-00986
• Device Sequence Number: 17047289
• Product Code: LZO
• UDI-Device Identifier: 07630030809125
• UDI-Public: 07630030809125
• 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: 2014
• Device Explanted Year: 2023
• 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): 12/11/2023

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: 05/31/2019
• Device Catalogue Number: 01.29.201
• Device Lot Number: 141786
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2014
• 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