MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR FEM COMP SZ 14; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71306614

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 01/08/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed on the patient due to an infection.The only s&n device explanted is the femoral stem.No delay or additional injuries reported.

Manufacturer Narrative

The associated complaint device was not returned.A clinical evaluation was conducted and without the requested supporting clinical documents a thorough medical investigation cannot be rendered.Should information become available this complaint can be re-assessed.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This included a review of sterilization documents which indicated that the product was sterilized according to sterilization release documentation.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

Manufacturer Narrative

He associated complaint device was returned and evaluated.A visual inspection of the returned synergy porous femoral stem indicated scratches and damage along the body.There was also tissue/ bone present.A clinical analysis indicated without the requested supporting clinical documents a thorough medical investigation cannot be rendered.Should information become available this complaint can be re-assessed.A lab analysis indicated that the device was removed due to an infection.There was no failure observed on the device.Bone on-growth on stem and burnishing observed on neck on implant.Scratches observed on top of neck.No material or manufacturing deviations were observed.No destructive testing was performed on these retrieved components.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This included a review of sterilization documents which indicated that the product was sterilized according to sterilization release documentation.A review of complaint history on the listed part revealed no prior complaints for the listed batch.Based on this investigation, the need for corrective action is not indicated.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: SYN POR FEM COMP SZ 14
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8299083
• MDR Text Key: 134843504
• Report Number: 1020279-2019-00382
• Device Sequence Number: 1
• Product Code: JDH
• UDI-Device Identifier: 03596010194480
• UDI-Public: 03596010194480
• Combination Product (y/n): N
• PMA/PMN Number: P030022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2018
• Device Catalogue Number: 71306614
• Device Lot Number: 08EM12144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Date Manufacturer Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 78