MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3; HIP CEMENTLESS STEM

Model Number 01.12.033

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Inadequate Osseointegration (2646)

Event Date 01/28/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 16 february 2021: lot 152230: (b)(4) items manufactured and released on 16-july-2015.Expiration date: 2020-06-30.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.

Event Description

Revision surgery 4 years and 10 months after primary, for stem loosening.Stem, head and liner revised successfully.

Manufacturer Narrative

On 07-may-2021 batch review was corrected, here below the updated version.Batch review performed on 07 may 2021: lot :152230: (b)(4) items manufactured and released on 16-july-2015.Expiration date: 2020-06-30.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.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3
• Type of Device: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11453191
• MDR Text Key: 239795460
• Report Number: 3005180920-2021-00199
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802157
• UDI-Public: 07630030802157
• Combination Product (y/n): N
• PMA/PMN Number: K082792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/11/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: 01.12.033
• Device Catalogue Number: 01.12.033
• Device Lot Number: 152230
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/02/2021
• Initial Date FDA Received: 03/10/2021
• Supplement Dates Manufacturer Received: 04/02/2021
• Supplement Dates FDA Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR