MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 56; HIP ACETABULAR SHELL

Catalog Number	01.26.56MB
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 march 2019: lot 157615: (b)(4) items manufactured and released on 22-mar-2016.Expiration date: 2021-03-08.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.Preliminary investigation performed by r&d project manager: preliminary investigation on pictures received shows the acetabular cup with bone tissue on the polar region.It is not possible to determine failure root cause.Clinical evaluation performed by medical affairs director: revision of primary cementless tha after an unspecified time period.According to report, the stem was well fixed and the reason for its removal is unclear.The cup, in the pre-revision xrays, appears mobilized, oversized and it seems to have violated the medial wall, but we do not know if this happened in the course of the postoperative time or if it was implanted in this position, for unknown reasons.Given the cup position and probably orientation, its mobilization should not be considered a problem related to the device.
Event or Problem Description
On (b)(6) 2019, we were alerted of a revision surgery planned on (b)(6) 2019 due to an unknown reason.On (b)(6) 2019 we received the information that the revision surgery was completed successfully via posterior approach, the main reason was cup loosening.The femoral stem was found to be in good position and solidly ingrown within the femur.The acetabular component was loose and easily removed, there was a small amount of bone attached to the polar region of the cup and this left a hole in the medial wall of the acetabulum.The acetabulum was prepared for two augments that were screwed into place, cup was positioned over these augments and bone graft, then cemented and screwed into position.A double mobility liner was cemented into the cup, prior to the 28mm ceramic option head being placed within the polyethylene head.The hip was reduced and closed, the patient leg length was longer due to the extensive acetabular reconstruction above.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL Ø 56
• Common Device Name: HIP ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8439902
• Report Number: 3005180920-2019-00176
• Device Sequence Number: 11207826
• Product Code: MEH
• UDI-Device Identifier: 07630030808173
• UDI-Public: 07630030808173
• 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
• Report Date (Section B): 03/21/2019

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: 03/08/2021
• Device Catalogue Number: 01.26.56MB
• Device Lot Number: 157615
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 03/21/2019
• 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: 78 YR