MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2, SHORT NECK; CEMENTLESS HIP STEM

Catalog Number	01.12.22SN
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11-nov-2019.Lot 143469: 20 items manufactured and released on 29-jul-2014.Expiration date: 2019-06-30.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs director.5 years after primary cementless tha the stem is removed due to pain.At reoperation, the surgeon reportedly remarked that osseointegration had not taken place in a satisfactory fashion, and this is probably the cause for pain and hence revision.According to report, this patient never felt comfortable with her thigh, so a possible explanation is that something may have prevented the stem from finding a good initial stability that allows osseointegration.With the information at hand, only unsupported hypotheses can be made on the root cause of the event.
Event or Problem Description
Revision surgery 5 years after the primary due to stem subsidence.The quadra stem was removed via a posterior approach, the surgeon commented that it had not bonded.A minimax stem was used to complete the revision surgery with a new ceramic head.A small amount of bone graft distally was also used.
Additional Manufacturer Narrative
Visual inspection: ha layer absorbed, signs of extraction on femoral neck.It is not possible to determine an implant related failure root cause.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2, SHORT NECK
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9400844
• Report Number: 3005180920-2019-01015
• Device Sequence Number: 2490791
• Product Code: JDI
• UDI-Device Identifier: 07630030802621
• UDI-Public: 07630030802621
• 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: 2014
• 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): 01/03/2020

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: 06/30/2019
• Device Catalogue Number: 01.12.22SN
• Device Lot Number: 143469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 01/03/2020
• 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: 78 YR