MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø58 TWO-HOLES; CEMENTLESS ACETABULAR SHELL

Catalog Number	01.32.158DH
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional comment provided by the surgeon: part of the learning curve with amis - had the same problem when doing daa without amis leg positioner, patient was very muscular, less than optimal exposure, used straight impaction handle, surgeon will join local expert for amis to gain tips and tricks, we will plan to go through the amis education program (amis lc and surgeon to surgeon) at the beginning of 2019.Batch review performed on 04 december 2018: lot 172588: (b)(4) items manufactured and released on 28-sep-2017.Expiration date: 2022-09-20.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 director on nov 30, 2018: acetabular component revision few days after implantation due to inaccurate positioning.Reasons for this may be due to patients' and/or surgical factors.There is no reason to suspect a faulty device.
Event or Problem Description
Post-op x-ray revealed extremely vertical cup (inclination of around 68 degrees), the joint was stable and the shell was well fixated (good primary stability achieved intra op), but the surgeon decided to revise the implant on (b)(46 2018 (7 days after primary surgery).Revision through amis approach was performed, misplaced 58 mm cup was removed, reaming performed and a new 60mm mpact was implanted.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø58 TWO-HOLES
• Common Device Name: CEMENTLESS ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8133921
• Report Number: 3005180920-2018-00961
• Device Sequence Number: 13925134
• Product Code: LPH
• UDI-Device Identifier: 07630030810893
• UDI-Public: 07630030810893
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2018

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: 09/20/2022
• Device Catalogue Number: 01.32.158DH
• Device Lot Number: 172588
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 12/05/2018
• 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: 58 YR
• Patient Weight: 92