MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN REFLECTION METAL CUP; PRSTHSS,HP,HM-, TRUNNION-BEARING,FEMORAL,MTL/POLYACETAL

Catalog Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Pain (1994); Injury (2348); Neuralgia (4413); Joint Laxity (4526)

Event Date 06/19/2020

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to pain and dislocation.The doctor said s+n devices were not defective.Primary surgery date is unknown.Cup and head (2 devices) were exchanged.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation, therefore the failure could not be confirmed.The clinical/medical team concluded, this complaint from japan reports the revision of a hip was secondary to ¿pain and dislocation¿ ¿the doctor says smith & nephew devises were not defective¿.The cup and head (2 devices ) were exchanged.The impact to the patient beyond the additional surgery and recovery cannot be determined.It has been communicated, that no further documentation will be forthcoming.Smith and nephew has not received adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKNOWN REFLECTION METAL CUP
• Type of Device: PRSTHSS,HP,HM-, TRUNNION-BEARING,FEMORAL,MTL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10268206
• MDR Text Key: 198680781
• Report Number: 1020279-2020-03157
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• 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: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention