MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 4; HIP CEMENTLESS STEM

Catalog Number	01.12.34SN
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	05/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 june 2019: lot 170887: (b)(6) items manufactured and released on 23 august 2017.Expiration date: 2022-07-20.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.Another device was involved in the complaint.Batch review performed on 18 june 2019: cup: versafitcup 01.26.52mb acetabular shell ø 52, lot.177261 (k083116): (b)(4) items manufactured and released on 28 february 2018.Expiration date: 2023-02-20.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
On may 22 we were informed about a revision surgery performed on may 23.The patient had hip pain and was instable.The patient was 1.5cm short on the operated side.Once inside the surgeon noticed a large pseudotumor and numerous similar membranes.The primary diagnosis was loosening of the stem as it appears to have subsided causing the secondary diagnosis of instability.So about 7 months after primary the surgeon removed the stem and due to the pseudotumor and reaction in the joint he decided to also remove the cup.The surgeon suggested that there is evidence of impingement of the neck and the side of the cup.All medacta components were removed and other company implants were implanted.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager: femoral stem: neck with deep scratches, unknown reason, no sign on the acetabular shell rim that suggest repeated impingement events.Stem with bone residuals and ha layer still intact.Deep scratches are visible.Acetabular cup: scratches of unknown reason on the internal surface.Outer region shows bone residuals.Dm pe liner: highly scratched on the external equatorial edge.Femoral head: no particular signs.It is not possible to determine a failure root cause.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 4
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8711639
• Report Number: 3005180920-2019-00495
• Device Sequence Number: 2663547
• Product Code: LZO
• UDI-Device Identifier: 07630030802744
• UDI-Public: 07630030802744
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 07/23/2019

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: 07/20/2022
• Device Catalogue Number: 01.12.34SN
• Device Lot Number: 170887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 07/23/2019
• 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: 71 YR
• Patient Weight: 86