MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT DOUBLE MOBILITY SHELLS; HIP ACETABULAR SHELL

Model Number	01.32.150MB
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	07/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 august 2024: lot 2249708: (b)(4) items manufactured and released on 18-jul-2023.Expiration date: 2028-07-02.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.Visual inspection performed by r&d manager: from the received parts, no particular signs were visible, especially in the dm polyethylene liner and ceramic ball head.On the acetabular cup, only some stains of blood and other bone/fibrotic tissue were present.From the received parts it is not possible to determine the root cause of the event.
Event or Problem Description
At 9 months from the primary, the patient came in reporting pain due to a loose cup and the cause is unknown.The surgeon revised the head, cup and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Additional devices involved batch review performed on 30 september 2024: liner: mpact dm double mobility hc liner 28/dme (k092265) lot 2305338: (b)(4) items manufactured and released on 21-jun-2023.Expiration date: 2028-06-03.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.Ball heads: mectacer biolox delta ceramica 12/14 ø 28 biolox delta ceramic ball head 12/14 ø 28 size s -3.5 (k112115) lot 2335080: (b)(4) items manufactured and released on 29-aug-2023.Expiration date: 2028-07-26.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.Updated device sales: batch review performed on 30 september 2024 cup: mpact double mobility acetabular shell ø50 (k143453) lot 2249708: (b)(4) items manufactured and released on 18-jul-2023.Expiration date: 2028-07-02.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.Updated visual inspection: from the received parts, no particular signs were visible, especially in the dm polyethylene liner and ceramic ball head.On the acetabular cup, only some stains of blood and other bone / fibrotic tissue were present.From the received parts it is not possible to determine the root cause of the event.Looking at the liner, the yellowing is probably due to lipid absorption that occurred during the patient's normal activity.

• Brand Name: MPACT DOUBLE MOBILITY SHELLS
• Common Device Name: HIP ACETABULAR SHELL
• 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: 20088978
• Report Number: 3005180920-2024-00686
• Device Sequence Number: 12676343
• Product Code: LPH
• UDI-Device Identifier: 07630030860966
• UDI-Public: 07630030860966
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K143453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2024

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 Model Number: 01.32.150MB
• Device Catalogue Number: 01.32.150MB
• Device Lot Number: 2249708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2023
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Race: White