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

Catalog Number	71306614
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/08/2019
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8299083
• Report Number: 1020279-2019-00382
• Device Sequence Number: 11250982
• Product Code: JDH
• UDI-Device Identifier: 03596010194480
• UDI-Public: 03596010194480
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: P030022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 01/10/2019; 01/10/2019
• Initial Report FDA Received Date: 02/01/2019
• Supplement Report FDA Received Date: 06/11/2019; 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 78