MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II COCR PS NP FEMORAL COMP SZ 7 LEFT; PROSTHESIS KNE PATELLOFEMOROTIBIAL SEMICONSTRAINED CMNTD POLYMERMETALPOLYMER

Model Number	71420108
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery it was noticed that the component was damaged.There was no backup device available so procedure had a delay of an hour while backup from smith and nephew arrived.
Additional Manufacturer Narrative
Additional info: a2, a2, d10, g7, g9, h2, h3, h6, h10.Results of investigation: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device is damaged on one of the condyles.The device was manufactured in 2018.The product evaluation determined the damage to the device was actually an incomplete finish that occurred during the manufacturing process.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.Although the device failed to meet manufacturing specification, we consider this failure isolated at this time.The potential probable cause of the reported event is likely a manufacturing process error.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 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: GEN II COCR PS NP FEMORAL COMP SZ 7 LEFT
• Common Device Name: PROSTHESIS KNE PATELLOFEMOROTIBIAL SEMICONSTRAINED CMNTD POLYMERMETALPOLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8844088
• Report Number: 1020279-2019-02859
• Device Sequence Number: 16903820
• Product Code: JWH
• UDI-Device Identifier: 03596010205988
• UDI-Public: 03596010205988
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K951987
• 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): 02/25/2020

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: 71420108
• Device Catalogue Number: 71420108
• Device Lot Number: 18MM10888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR