MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP IMPLANT; PRSTHSIS, HIP, HMI-, TRNNION-BRING, FMRL, MTL/PLYCTL

Catalog Number 71331750

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Swelling (2091); Injury (2348)

Event Date 12/13/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed because patient had pseudotumors.

Manufacturer Narrative

New information received upon investigation team approval.It was reported that a revision surgery was performed due to patient pseudotumors.The affected r3 3 hole acetabular shell, anthology porous stem, r3 32mm delta ceramic liner and ceramic head, used in treatment, were returned and evaluated.A lab analysis conducted during this investigation noted that on the femoral component gouge marks and an extensive biological on-growth in the proximal porous region are observed on the device.Marks most likely occurred during removal.This provides some indication of a well-fixed stem at the time of its removal.No physical damage or wear observed around the diameter of the locking taper.This implies the head was properly lock to the femoral component.The ceramic head did not reveal any physical damage but marks of metal transfer during removal are noted on the articular surface and lower side of head.The od porous surface of the shell exhibited biological on-growth, which suggests the shell was well-fixed at the time of revision.Dark scuff marks typical of metal transfer during implant revision are noted on the liner.From information presented and visual observations, there is no evidence to support any conclusion regarding the reported issue.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident or adverse event 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.We will continue to monitor for future complaints and investigate as necessary.

Event Description

It was reported that a revision surgery was performed because patient had pseudotumors.During investigation of the device dark scuff marks were found on the liner.This was the only device were this wear was found.Pseudo tumour is offently linked to metal issues.

• Brand Name: HIP IMPLANT
• Type of Device: PRSTHSIS, HIP, HMI-, TRNNION-BRING, FMRL, MTL/PLYCTL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; spa park; memphis TN 38116
• MDR Report Key: 8190241
• MDR Text Key: 131180116
• Report Number: 3005975929-2018-00545
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71331750
• Device Lot Number: 11BT03637
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: P#71331950 L#11CM14870; P#71357004 L#10EM08802; P#UNKNOWN HIP IMPLANT L#UNKNOWN; UNKNOWN BHR DEVICE; UNKNOWN BHR DEVICE
• Patient Outcome(s): Hospitalization; Required Intervention