MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II 7.5MM RESUR PAT 32MM; PROST, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLY/MET/POLY

Catalog Number	71932636
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	10/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2020, the patient came to the hospital due to pain.An x-ray was performed where it was observed the patella component was disassociated.Therefore, revision surgery was performed on (b)(6) 2020.
Additional Manufacturer Narrative
Updated : lot number/ exp date and udi and mnf date.
Additional Manufacturer Narrative
H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device shows damage and gouges around the edges of the part.Cement debris are observed on the inferior surface of the device.The clinical/medical concluded that based on the documentation provided, the root cause of the disassociation could not be definitively concluded.It is unknown, however, if there were pre-existing conditions and/or trauma prior to the onset of pain, but the product evaluation noted damage and gouges around the edges of the part.The assessed patient impact was the disassociated component and the patellar revision.Further patient impact could not be determined but the issue was reportedly ¿resolved¿.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.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.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Some potential causes could include but are not limited to traumatic injury, surgical technique or size of device.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 7.5MM RESUR PAT 32MM
• Common Device Name: PROST, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLY/MET/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10819675
• Report Number: 1020279-2020-06359
• Device Sequence Number: 1114287
• Product Code: JWH
• UDI-Device Identifier: 00885556056721
• UDI-Public: 885556056721
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/27/2021

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71932636
• Device Lot Number: 18AM10860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 10/22/2020; 07/23/2021
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 12/04/2020; 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 74022214 TIB BSE/74027232 ART ISRT/74022114 FEM OX; 74022214 TIB BSE/74027232 ART ISRT/74022114 FEM OX
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention