MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SYSTEM; HIP ACETABULAR CUP

Model Number	01.32.158DH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	02/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23-feb-2024: lot 2203932: (b)(4) items manufactured and released on 11-may-2022.Expiration date: 2027-04-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Additional component involved in the event: batch review performed on 08-mar-2024: liner: mpact 01.32.4048hct flat pe hc liner ø40/f (k122641) lot 2209949: (b)(4) items manufactured and released on 30-jun-2022.Expiration date: 2027-06-12.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
At about 1 year and 2 months after primary, the patient came in for a post-op appointment and post op x-rays indicated osteolysis behind the acetabular shell and the cause is unknown.The surgeon revised the cup, head and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Additional device involved: batch review performed on 07-oct-2024 on ball heads: mectacer 01.29.213 biolox delta ceramic ball head 12/14 ø 40 size m 0 (k112115) lot.2209213.Lot 2209213: (b)(4) items manufactured and released on 20-jul-2022.Expiration date: 2027-07-11.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 07-oct-2024 on cup: mpact 01.32.158dh acetabular shell ø58 two-holes (k132879) lot.2203932.Lot 2203932: (b)(4) items manufactured and released on 11-may-2022.Expiration date: 2027-04-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Batch review performed on 07-oct-2024 on liner: mpact 01.32.4048hct flat pe hc liner ø40/f (k103721) lot.2209949.Lot 2209949: (b)(4) items manufactured and released on 30-jun-2022.Expiration date: 2027-06-12.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported case during the period of review.

• Brand Name: MPACT ACETABULAR SYSTEM
• Common Device Name: HIP ACETABULAR CUP
• 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: 18865904
• Report Number: 3005180920-2024-00115
• Device Sequence Number: 8148385
• Product Code: LPH
• UDI-Device Identifier: 07630030810893
• UDI-Public: 07630030810893
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

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: 01.32.158DH
• Device Catalogue Number: 01.32.158DH
• Device Lot Number: 2203932
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2022
• 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