MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø48 MULTI-HOLE; CEMENTLESS HIP SHELL

Catalog Number	01.32.148MH
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 january 2018: lot 166617: (b)(4) items manufactured and released on 25-jan-2017.Expiration date: 16.01.2022.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs manager: cup mobilization occurred in an elderly woman ((b)(4) year old) 4 weeks after surgery.No immediate postoperative x-ray is available.On the basis of the information received, no conclusion can be drawn.
Event or Problem Description
On (b)(6) 2018 we were informed that a patient was revised 4 weeks after primary due to cup dislocation.
Additional Manufacturer Narrative
Additional info received from the sales rep on 25 february 2019: the surgeon removed the implants from the cup side and revised the patient with a custom made implant.Cup - screws - liner revised.The revision was due to a secondary move of the cup.Primary surgery performed on (b)(6) 2018.Revision surgery performed on (b)(6) 2018.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø48 MULTI-HOLE
• Common Device Name: CEMENTLESS HIP SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8264000
• Report Number: 3005180920-2019-00001
• Device Sequence Number: 2370778
• Product Code: LPH
• UDI-Device Identifier: 07630030810749
• UDI-Public: 07630030810749
• 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: 2019
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2019

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: 01/16/2022
• Device Catalogue Number: 01.32.148MH
• Device Lot Number: 166617
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 01/21/2019
• Supplement Report FDA Received Date: 03/26/2019
• 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