MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 3 LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number 71420164

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference case: (b)(4).

Event Description

It was reported that (b)(4) units, manufactured in 128 lots from 3 catalogue numbers of genesis iitibial base plates (71420164, 71420166 and 71420184), were removed from the field for scrapping.At the (b)(4) site on 14 feb 2020, a non-homogenous material issue was detected in the machined base plate.The inclusion that was detected is a hard, brittle alpha phase enriched with oxygen and nitrogen.The hard-brittle alpha phase increases the risk of voids building in the bar rolling process.Both the presence of the hard, brittle phase as well as the presence of voids could potentially increase the risk of premature fatigue failure, particularly in high stress areas of the device.As s+n has not received any product complaint associated to this issue, s+n is reporting pursuant 21 cfr 806, for the remedial action that was taken.

Manufacturer Narrative

H3, h6: given the nature of the confirmed incident, the devices did not need to be returned for this investigation to take place because the event was detected during the manufacturing process.A non-homogeneous material issue was noted on two units at the tuttlingen site and the reported event could be confirmed.A review of the manufacturing records performed during the health hazard evaluation revealed that out of the 2766 parts that were machined with the affected material, 235 of semi-finished parts were blocked internally or internally scrapped.A review of complaint history was also performed during the health hazard evaluation and did not reveal any additional complaints for the affected lot numbers.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.At this time, we do have reason to suspect that the product failed to meet product specifications at the time of manufacture.The root cause of the material defect originated from the raw material bars that smb (supplier) sources from tifast (subcontractor).A metallographic analysis of the defect determined that the affected zone showed an inclusion with increased monophasic alpha-phase content enriched with oxygen and nitrogen in the affected zone.The defective bars were not detected at tifast because there was a malfunction of the ultrasonic testing equipment for this batch.¿the contribution of the device to the reported event could be corroborated since the material defect could provoke an early implant failure and a recall was put in place to prevent this from happening.As a result of the investigation, a block was put for the subcontractor by direct supplier until completion of corrective and preventive actions at the subcontractor and an expansion of random sampling of raw material suppliers through supplier audits will also be put in place.In addition, containment and remedial actions were performed for the impacted finished product.Based on this investigation, the need for corrective action is indicated.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GNS II CMT TIB SIZE 3 LEFT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12942483
• MDR Text Key: 285149123
• Report Number: 1020279-2021-08536
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010206251
• UDI-Public: 03596010206251
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 71420164
• Device Catalogue Number: 71420164
• Device Lot Number: SEVERAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 12/06/2021
• Supplement Dates Manufacturer Received: 06/30/2020; 06/03/2022
• Supplement Dates FDA Received: 12/07/2021; 06/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1951-2021
• Patient Sequence Number: 1