MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 5-6 15MM; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Model Number	71453224
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, right after removing the original insert, the surgeon implanted a patella and thoroughly cleaned and cleared the tibial base plate and surrounding tissue to insert the replacement poly.After 3 failed attempts to lock down the poly a second back up poly was opened and impacted down correctly on the first attempt.It is unknown if there was any delay nor injury reported.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned device shows damage on the lock detail probably from the attempted insertion.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing or product specifications for batch did not reveal abnormalities that could have contributed to the reported issue.A review of the risk management file and instructions for use document for this failure mode was conducted and concluded this failure mode has been identified.Our clinical/medical team noted: this complaint reports that during a revision the poly insert would not lock down after 3 attempts, so a backup device was used to complete the procedure.Per email communication, the requested x-rays and surgical reports will not be provided due to no consent being given.Therefore, no further medical assessment can be performed at this time.Should clinically relevant documentation/ information become available, the clinical/medical task may be re-evaluated.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint, however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 5-6 15MM
• Common Device Name: PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10166208
• Report Number: 1020279-2020-02480
• Device Sequence Number: 2102057
• Product Code: JWH
• UDI-Device Identifier: 00885556033913
• UDI-Public: 00885556033913
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2021

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: 71453224
• Device Catalogue Number: 71453224
• Device Lot Number: 16CT65879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention