MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 6; HIP CEMENTLESS STEM

Catalog Number	01.12.026
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	04/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 apr 2019: lot 156215: (b)(4) items manufactured and released on 15-jan-2016.Expiration date: 2021-01-02.No anomalies found related to the problem.To date, (b)(4) items of this same lot have been already sold without any other similar reported event.Other devices were involved in the event: ball heads: mectacer 01.29.214 biolox delta ceramic ball head 12/14 ø 40 size l + 4 lot.150463 (k112115): (b)(4) items manufactured and released on 10-apr-2015.Expiration date: 2020-02-29.No anomalies found related to the problem.To date, (b)(4) items of this same lot have been already sold without any other similar reported event.Cup: mpact 01.32.158dh acetabular shell ø58 two-holes lot.162911 (k132879): (b)(4) items manufactured and released on 22-jun-2016.Expiration date: 2021-06-01.No anomalies found related to the problem.To date, all the items of this same lot have been already sold without any other similar reported event.Liner: mpact 01.32.4048hct flat pe hc liner ø40/f lot.157212 (k122641): (b)(4) items manufactured and released on 05-feb-2016.Expiration date: 2021-01-19.No anomalies found related to the problem.To date, (b)(4) items of this same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs director: femoral component revision surgery occurred 2 years and 7 months after cementless total hip arthroplasty in a heavy (b)(6) man.Radiographic images provided show the presence of osteolytic zones around the stem and bone quality alterations in the greater trochanter region.According to the report and the radiological findings, an infection could be a possible cause of this event.However, on the basis of the information received, this hypothesis cannot be confirmed.
Event or Problem Description
About 2 years and 9 months after primary the surgeon revised the patient hip for a suspected infection.The stem come out easy from femur during the revision.The stem was revised.The surgery was completed successfully.
Additional Manufacturer Narrative
Visual inspection performed by the r&d project manager on the stem received: femoral stem shows ha layer still intact on the proximal part of the stem.Signs due to revision on the neck.In the event description has been added that also the head has been revised.
Event or Problem Description
About 2 years and 9 months after primary the surgeon revised the patient hip for a suspected infection.The stem come out easy from femur during the revision.The stem and the head were revised.The surgery was completed successfully.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 6
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8577873
• Report Number: 3005180920-2019-00340
• Device Sequence Number: 13862781
• Product Code: JDI
• UDI-Device Identifier: 07630030802072
• UDI-Public: 07630030802072
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 06/26/2019

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: 01/02/2021
• Device Catalogue Number: 01.12.026
• Device Lot Number: 156215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 06/26/2019
• 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: 69 YR
• Patient Weight: 100