MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER Ø 32 / C; HIP SHELL LINER

Catalog Number 01.26.3239HCT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unequal Limb Length (4534)

Event Date 11/09/2023

Event Type  Injury  

Event Description

The patient came in reporting pain and instability due to a leg length discrepancy.About 1 year and 11 months after the primary surgery, the surgeon revised the head, cup and liner.The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 16 november 2023: lot 2111759: (b)(4) items manufactured and released on 14-sep-2021.Expiration date: 2026-aug-31.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 devices involved batch review performed on 16 november 2023.Ball heads: mectacer 01.29.206 biolox delta ceramic ball head 12/14 ø 32 size l +4 (k112115) lot 2009397: (b)(4) items manufactured and released on 19-jan-2021.Expiration date: 2026-jan-07.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 cc trio 01.26.45.0046 acetabular shell cc trio ø 46 (k103352) lot 2104085: (b)(4) items manufactured and released on 15-jul-2021.Expiration date: 2026-jul-04.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.

• Brand Name: LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER Ø 32 / C
• Type of Device: HIP SHELL LINER
• 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: 18266626
• MDR Text Key: 329727454
• Report Number: 3005180920-2023-00962
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030807541
• UDI-Public: 07630030807541
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/05/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 01.26.3239HCT
• Device Lot Number: 2111759
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female