MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø66 MULTI-HOLE; HIP UNCEMENTED SHELL

Model Number	01.32.166MH
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	02/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 6 march 2020: lot 156005: (b)(4) items manufactured and released on 22-mar-2016.Expiration date: 2021-03-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar events reported.Clinical evaluation performed by medacta medical affairs director: few weeks after revision arthroplasty of the hip in a patient showing an undefined form of osteomalacia the cup violates the acetabular floor and gets loose.Given the difficulty of the case, whose situation is not fully described, we can only conclude that this cup could never find a satisfactory primary stability and therefore tilted.The cause of this failure is not to be sought in a defective device.
Event or Problem Description
Revision surgery performed 9 days after the primary due to cup mobilization.The surgeon revised the cup, head and insert.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø66 MULTI-HOLE
• Common Device Name: HIP UNCEMENTED SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9872198
• Report Number: 3005180920-2020-00178
• Device Sequence Number: 524881
• Product Code: LPH
• UDI-Device Identifier: 07630030811067
• UDI-Public: 07630030811067
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2020

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: 03/09/2021
• Device Model Number: 01.32.166MH
• Device Catalogue Number: 01.32.166MH
• Device Lot Number: 156005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR