MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN FEM HEAD INSTR; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number UNKN01400210

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2024

Event Type  malfunction  

Event Description

It was reported that during a thr, when impacting the unknown fem head instr, the plastic head split in half.Surgery was performed, without any delay, with the same device.No patient complications were reported.

Manufacturer Narrative

Internal reference number: case (b)(4).

Manufacturer Narrative

H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.Device specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, risk management file and prior actions could not be performed.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Additional information: d5, d7a, d8, g2, h8 corrected data: b5.

Event Description

It was reported that during a thr, when impacting the femoral head, the plastic head of an unknown femoral head impactor split in half.No pieces fell into patient.Surgery was performed, without any delay, with the same device.No patient complications were reported.

• Brand Name: UNKN FEM HEAD INSTR
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19034444
• MDR Text Key: 339270547
• Report Number: 1020279-2024-00674
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01400210
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1