MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHEM FEMORAL PS COCR SZ 4 RT; PROSTHESIS, KNEE, PATELLOFEMTIB, SEMI-CONSTRAIND, CEMENTD, POLY/METAL/POLY

Model Number	71422834
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during surgery while implantation, it was found that an anthem femoral ps cocr sz 4 rt was implanted but there were no stickers in the box, as the stickers are inside the box, in the process, nurse opened the box, hand over implants one after another, once the implantation was done the nurse gather the stickers and handover to us.But in the femoral box there were no stickers.The size implanted in the patient was the correct size.No patient injury / impact resulted from the reported event, patient was discharged after a successful surgery.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.The clinical/medical investigation concluded that, based on the information provided, the root cause of the reported event could not be definitively concluded; however, human/procedural error during manufacturing/packaging/labeling could not be ruled out as the stickers were reportedly missing from box.Additionally, it was communicated that during implantation the stickers are gathered ¿once the implantation is done¿.Best practice recommendation is to confirm the shipped component matches the outer container labeling as well as the chartstiks/stickers prior to implantation.Reportedly, no patient impact resulted from the reported event as the procedure was successfully completed as planned with the correct components without delay and no additional interventions were required.No further medical assessment can be rendered at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.According to the packaging sequence, the stickers should be inside the implant box.A review of complaint history did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.The contribution of the device to the reported event could not be corroborated.At this time, we have no evidence to suspect that the product failed to meet any product specifications at the time of manufacture.Mishandling or manufacturing process errors could be probable causes of the reported event.With no other complaints for the batch, we consider this an isolated event.However, we will continue to monitor this failure mode in the future.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, 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: ANTHEM FEMORAL PS COCR SZ 4 RT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMTIB, SEMI-CONSTRAIND, CEMENTD, 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: 11103201
• Report Number: 1020279-2020-08131
• Device Sequence Number: 4125702
• Product Code: JWH
• UDI-Device Identifier: 00885556531310
• UDI-Public: 00885556531310
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K142807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71422834
• Device Catalogue Number: 71422834
• Device Lot Number: 19KM00295A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 12/31/2020
• Supplement Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2019
• 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