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

Catalog Number UNKNOWN

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

Patient Problem Joint Dislocation (2374)

Event Date 02/20/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that, after an unknown s&n hip system had been implanted, the patient has suffered multiple dislocations.The patient has not been revised.The event is ongoing.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.There is no information that would suggest the device failed to meet specifications.As device information was not made available, device history record and complaint history review cannot be completed.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.The potential probable causes for this event could include but not limited to a user or procedural error.According to clinical/medical investigation, ¿hip keeps dislocating¿with very little movement¿ due to ¿an anatomical anomalous pelvic dysplastic condition where even limited no dramatic movements my pelvis hits the femoral stem popping the ball from the even 2 liner socket¿.Responses to the medical documentation requests have not been received as of the date of this medical investigation.The reported root cause is the dysplastic anomaly; however, this cannot be confirmed nor concluded.The patient impact beyond the reported recurrent dislocations could not be determined.No further medical assessment could be rendered at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-opened for further evaluation.Based on this investigation, the need for corrective action is not indicated.A review of risk management files and the instructions for use found that the probable cause failures were documented appropriately.The potential probable causes for this event could include but not limited to a patient condition, user or procedural error.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 SMITH+NEPHEW 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: 11479815
• MDR Text Key: 239666388
• Report Number: 1020279-2021-02152
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention