MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PRESSFIT STEM 14MM X 120MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CNSTRND, CEMENTED, POLY/METAL/POLY

Model Number	71424027
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the label on the packaging is not compliance.It does not contain the sku number.No case involved.
Additional Manufacturer Narrative
H3, h6: the associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device box label is cut off and missing the catalog number and quantity.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have reason to suspect that the product failed to meet product specifications at the time of manufacture.The potential probable cause for this event is likely a manufacturing process error.This issue is being evaluated through our internal quality hold process.Based on this investigation, the need for corrective action is indicated.Should additional information be received, the complaint will be reopened.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.
Additional Manufacturer Narrative
The associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device box label is cut off and missing the catalog number and quantity.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have reason to suspect that the product failed to meet product specifications at the time of manufacture.The potential probable cause for this event is likely a manufacturing process error.This failure mode had been previously identified and the device was re-designed to prevent the reoccurrence of this failure mode.The returned device was manufactured prior to these design changes.This issue is being evaluated through our internal quality hold process.Based on this investigation, the need for corrective action is indicated.Should additional information be received, the complaint will be reopened.Should additional information be received, the complaint will be reopened.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.
Additional Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event, because of the following reason: the nonconformity was identified in a smith and nephew warehouse in three devices (report numbers: 1020279-2021-00488, 1020279-2021-00487) and actions have been taken to address the problem internally within the smith and nephew quality system.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.Internal reference number: (b)(4).

• Brand Name: LGN PRESSFIT STEM 14MM X 120MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CNSTRND, CEMENTED, POLY/METAL/POLY
• 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: 11188741
• Report Number: 1020279-2021-00451
• Device Sequence Number: 3583287
• Product Code: JWH
• UDI-Device Identifier: 03596010546678
• UDI-Public: 03596010546678
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/24/2021

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
• Operator of Device: Health Professional
• Device Model Number: 71424027
• Device Catalogue Number: 71424027
• Device Lot Number: 20DSM0127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2020
• Supplement Date Received by Manufacturer: 06/22/2021; 10/08/2021; 10/08/2021
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 06/23/2021; 10/11/2021; 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown