MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL 50; HIP ACETABULAR SHELL

Model Number	01.26.50MB
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 sep 2019: lot 164501: 90 items manufactured and released on 28-oct-2016 expiration date: 13/10/2021.No anomalies found related to the problem.To date, 86 items of the same lot have been already sold without any other similar reported event clinical evaluation performed by medacta medical affairs director: revision surgery performed 2 years after cementless double-mobility total hip arthroplasty in a 66 year old woman.The patient was complaining about hip instability.Acetabular component looks slightly horizontal in the radiographic image provided and probably caused impingement between stem and cup.The reason of this position cannot be determined on the basis of a single pre-revision x-ray.Furthermore, it is not known if lumbar fusion devices were already in place at time of primary surgery, but this is a potentially seriously contributing factor because the pelvis position has probably been altered.The reason of this event cannot be determined.Preliminary investigation performed by medacta hip r&d project manager: from preliminary visual investigation it is not possible to determine any implant related failure root cause.
Event or Problem Description
Surgeon was performing an exploratory surgery to identify why the patient was unstable in the hip after about 2 years from primary surgery (right side).There was impingement between stem and cup due to cup placement.Shell, head and liner revised successfully.
Event or Problem Description
In this complaint (b)(4) was not reported that metallosis has been revealed.A follow-up to the competent authority must be reported.Due to the root cause and analysis performed no new batch review has been necessary nor statistical analysis.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL 50
• Common Device Name: HIP ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9179242
• Report Number: 3005180920-2019-00863
• Device Sequence Number: 11540026
• Product Code: MEH
• UDI-Device Identifier: 07630030808067
• UDI-Public: 07630030808067
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2020

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: 10/13/2021
• Device Model Number: 01.26.50MB
• Device Catalogue Number: 01.26.50MB
• Device Lot Number: 164501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 04/23/2020
• 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: 66 YR
• Patient Weight: 80