MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0; HIP CERAMIC HEAD

Model Number	01.29.202
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting anterior groin pain and the cause is unknown.Bone scan was good and the patient was negative for any infection.There was a soft tissue mass that appeared on one of the scans.About 9 months after the primary surgery, the surgeon revised the medacta cup and liner with a competitor cup and liner and revised the medacta head with a medacta head.During surgery, it was found that the anterior capsule and the surrounding tissue were very thick and leathery.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 21 april 2023: lot 2119449: (b)(4) items manufactured and released on 22-apr-2022.Expiration date: 2027-apr-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Additional device involved batch reviews performed on 21 april 2023: liner: versafitcup dm 01.26.2854mhc double mobility hc liner ø 54/28 (k092265) lot 2103100: (b)(4) items manufactured and released on 26-may-2021.Expiration date: 2026-may-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Cup: versafitcup 01.26.54mb acetabular shell cc ø 54 (k083116) lot 2109799: (b)(4) items manufactured and released on 27-jan-2022.Expiration date: 2027-jan-10.No anomalies found related to the problem.To date, (b)(4) 53 items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0
• Common Device Name: HIP CERAMIC 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: 16893408
• Report Number: 3005180920-2023-00354
• Device Sequence Number: 6162761
• Product Code: LZO
• UDI-Device Identifier: 07630030809132
• UDI-Public: 07630030809132
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2023

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: 04/22/2022
• Device Model Number: 01.29.202
• Device Catalogue Number: 01.29.202
• Device Lot Number: 2119449
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2022
• 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: Male