MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN FEM CERAMIC HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Failure of Implant (1924); Osteolysis (2377); Fibrosis (3167)

Event Date 03/29/2017

Event Type  Injury  

Manufacturer Narrative

Complaint reference: (b)(4).

Event Description

It was reported that, in 2017, a first revision surgery with change of the insert and ball head was carried out due to wear (right body side).Original implantation was in 2001.

Manufacturer Narrative

Investigaiton results: it was reported that, in 2017, a first revision surgery with change of the insert and ball head was carried out due to wear.The complained unknown femoral head used in treatment, was not returned for investigation nor was a device or batch number communicated.An appropriate investigation could therefore not be conducted and the reported issue could not independently be confirmed.A medical investigation was conducted.The provided x-rays and medical records did not lead to a clear conclusion for the reported wear of the insert.The ifu (lit.No.12.23 ed 05/16) identifies wear as a known risk factor in combination with a hip arthroplasty.A review of the risk management documentation verifies the failure mode and severity of the reported issue.Based on available information the root cause for the reported issue cannot be determined.The need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor this device for similar issues.The complaint will be reopened should the complained device be received.

• Brand Name: UNKN FEM CERAMIC HEAD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11369407
• MDR Text Key: 233265358
• Report Number: 9613369-2021-00078
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2021
• Initial Date FDA Received: 02/23/2021
• Supplement Dates Manufacturer Received: 02/25/2021
• Supplement Dates FDA Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention