MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 58/28; HIP DOUBLE MOBILITY HIGHCROSS LINER

Catalog Number	01.26.2858MHC
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 20 days after the primary surgery, revision surgery performed due to dissociation of the inox head from the liner dm.Originally the joint dislocated and it appears that during the close reduction the head dissociated from the liner dm.The surgeon revised successfully the head and liner (same size).
Additional Manufacturer Narrative
Batch review performed on 29 april 2024 lot 2337367: (b)(4) items manufactured and released on 08-nov-2023.Expiration date: 2028-10-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Visual inspection performed by r&d project manager: from the received parts, an analysis on the dm liner was done, resulting in no particular or evident signs of damage.The dimension of the retentive diameter was detected, resulting almost in specification, but probably slightly increased (0.08mm) probably caused after the event and the subsequent managing (washing, sterilization, storage and shipment to medacta).From the received information it is not possible to determine with certainty the root cause of the event, but a possible cause can be related to a blockage of the liner, probably caused by soft tissues, that caused a leverage with which the ball head snapped off.Clinical evaluation performed by medical affairs department: revision surgery few days after the tha surgery due to dislocation of the head from the liner dm.Originally the joint dislocated and it appears that during the reduction the head dissociated from the liner dm.The dislocation may have happened due to many reasons such as malpositioning of the cup or a particular anatomy of the patient or insufficient tensioning of the sfot tissues.While the dissociation of the head from the liner is a rare case but it may be possible that appling an extreme force for the reduction may have caused the dissociation.Additional implants involved: batch review performed on 29 april 2024 on ball heads: inox 25055.2803 ball head 12/14 ø 28 size m 0 lot.2304591.Lot 2304591: (b)(4) items manufactured and released on 06-sep-2023.Expiration date: 2028-08-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Item not registered in us.Batch review performed on 03 may 2024 on cup: versafitcup 01.26.58mb versafitcup metalback dm ø58 mm (k083116) lot.2247222.Lot 2247222: (b)(4) items manufactured and released on 20-april-2023.Expiration date: 2028-04-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 58/28
• Common Device Name: HIP DOUBLE MOBILITY HIGHCROSS 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: 19237993
• Report Number: 3005180920-2024-00280
• Device Sequence Number: 8143065
• Product Code: MEH
• UDI-Device Identifier: 07630030807442
• UDI-Public: 07630030807442
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/03/2024

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 Catalogue Number: 01.26.2858MHC
• Device Lot Number: 2337367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2023
• 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: 80 YR
• Patient Sex: Male
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White