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

Catalog Number	01.32.158DH
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 june 2019: lot 164345: (b)(4) items manufactured and released on 29 august 2016.Expiration date: 2021-08-17.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in, 2 years and a half after primary surgery, complaining of pain due to a malposition of the cup.The surgeon revised the medacta cup and liner with a competitor's product and revised another company's head with a medacta head.The surgery was completed successfully.
Additional Manufacturer Narrative
Clinical evaluation performed by medacta medical affairs director on (b)(6) 2019: acetabular component revision performed 2,5 years after implantation.In the radiographic image provided seems that the position of the cup is suboptimal, but we cannot determine if this is the consequence of an early mobilization due to sudden resume of activity (or small quasi-traumatic event) or if this was the original position of the cup.The reason of this position cannot be assessed having a single, antero-posterior pre-revision image: patient anatomy or bone morphology may be one reason.No reason to suspect that this event is due to a faulty device.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø58 TWO-HOLES
• Common Device Name: HIP UNCEMENTED CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8707243
• Report Number: 3005180920-2019-00489
• Device Sequence Number: 2387228
• 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: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

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: 08/17/2021
• Device Catalogue Number: 01.32.158DH
• Device Lot Number: 164345
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 07/30/2019
• 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