MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN ORTHOPAEDIC RECONSTRUCTION DEV; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 01/24/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that after a thr, the patient's implant snapped.Patient was hospitalized but it is unknown if a revision surgery has been performed yet.No additional details are available at this moment.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The affected complaint device, used in treatment, was not returned for evaluation.Therefore, a product analysis could not be performed.As device information was not made available, device history record, risk management review and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore, no medical assessment can be performed at this time.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: UNKN ORTHOPAEDIC RECONSTRUCTION DEV
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11392774
• MDR Text Key: 234013247
• Report Number: 1020279-2021-01723
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• 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
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other