MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII C/R HA POROUS FEM SZ 4RT; PRTHES, KNEE, PAT/FEMTIB, SEMI-CNSTAIND, UNCMNTD, POROUS, COAT, POLY/MET/POLY

Model Number	71422028
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the surgeon noted that the implant is scratched, and not suitable for implantation.Another femur was opened which was not scratched.A delay was reported than, or equal to 30 minutes.No impact to the patient reported.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.However, there was a photo provided that confirmed the failure mode.The device did have scratches on it.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Damage from misuse or rough handling are likely probable causes of the reported event.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or 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.

• Brand Name: GII C/R HA POROUS FEM SZ 4RT
• Common Device Name: PRTHES, KNEE, PAT/FEMTIB, SEMI-CNSTAIND, UNCMNTD, POROUS, COAT, POLY/MET/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10663666
• Report Number: 1020279-2020-05336
• Device Sequence Number: 19720639
• Product Code: MBH
• UDI-Device Identifier: 03596010496225
• UDI-Public: 03596010496225
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P040033
• 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
• Report Date (Section B): 05/17/2021

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 Expiration Date: 12/19/2025
• Device Model Number: 71422028
• Device Catalogue Number: 71422028
• Device Lot Number: 15KM17472A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1