MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1; CEMENTLESS HIP STEM

Catalog Number 01.12.031

Device Problems Material Fragmentation (1261); Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 12/10/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on (b)(6) 2019: lot 050833: 24 items manufactured and released on (b)(6) 2005.Expiration date: (b)(6) 2010.No anomalies found related to the problem.To date, all the items of this same lot have been already sold without any similar reported event.

Event Description

Revision surgery performed 13 years after primary due to peri-prosthetic metallosis on the proximal part of the stem and on the periphery of the non-medacta cup.No invasion of the joint capsule.Liner and head were ceramic implants.The surgeon revised the stem with a quadra r size 1.

Manufacturer Narrative

Visual inspection performed by r&d project manager visual inspection performed on 23rd september 2019.The ha coating of the stem was almost totally absorbed and lots of scratches were visible in the neck region, probably some occurred during the revision; anyway, it is not clear if some of these scratches are related to impingement with other products, as the competitor's cup geometry is unknown.From the received piece it is not possible to determine with certainty the root cause of the event, but it could be related to the competitor's cup.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1
• Type of Device: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8230879
• MDR Text Key: 132495431
• Report Number: 3005180920-2018-01076
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802133
• UDI-Public: 07630030802133
• 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: 10/17/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2010
• Device Catalogue Number: 01.12.031
• Device Lot Number: 050833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 01/09/2019
• Supplement Dates Manufacturer Received: 12/10/2018
• Supplement Dates FDA Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR