MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA HOODED PE HC FIXED LINER Ø 32 / F; HIP SHELL LINER

Catalog Number	01.26.3248HCAT
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08-may-2024: lot 154839: (b)(4) items manufactured and released on 26-nov-2015.Expiration date: 2020-11-09.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.Additional device involved batch review performed on 08-may-2024: ball heads: mectacer 01.29.231h head biolox option ø 32 (k131518) lot 142131: (b)(4) items manufactured and released on 31-oct-2014.Expiration date: 2019-09-30.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
The patient undergone a primary surgery on the (b)(6) 2015.On the (b)(6) 2018, the patient came in reporting squeaking in the hip joint.The surgeon revised successfully the ceramic liner and ball head and replaced them with a hooded pe hc liner ø 32 / f, head biolox ø32 and a sleeve size l.On the (b)(6) 2024, the patient has been revised due to multiple dislocations and it is unknown how they have been treated.Versafitcup and liner have been revised with competitor devices, while the ceramic ball head and sleeve have been revised with a medacta 28mm cocr head.

• Brand Name: HOODED PE HC FIXED LINER Ø 32 / F
• Common Device Name: 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: 19390102
• Report Number: 3005180920-2024-00366
• Device Sequence Number: 12685143
• Product Code: LZO
• UDI-Device Identifier: 07630030807602
• UDI-Public: 07630030807602
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• 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): 05/24/2024

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: 11/09/2020
• Device Catalogue Number: 01.26.3248HCAT
• Device Lot Number: 154839
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/26/2015
• 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