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: case (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.As device information was not made available, device history record and complaint history review cannot be completed.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.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: 11479827
• MDR Text Key: 239656286
• Report Number: 1020279-2021-02153
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

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: 02/20/2021
• Initial Date FDA Received: 03/15/2021
• Supplement Dates Manufacturer Received: 04/08/2021
• Supplement Dates FDA Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention