MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II RESURF PATELLA 41MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71926226
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/10/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had a bilateral arthrosopy with synovectomy and lateral release.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The medical investigation concluded that ,based on the information provided ,the root cause of the reported bilateral knee patellar clunk syndrome is likely due to the extensive scar tissue found in both the right and left knee during the procedure.(b)(4): based on the information provided the patient¿s morbid obesity weight of 298lbs, coupled with the product analysis for the right knee ps post, fatigue cycling with hyperextension most likely contributed to the post breakage from the insert.The impact to the patient beyond the revisions cannot be concluded.No further clinical assessment is warranted 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.A review of complaint history did not reveal additional complaints for the listed batches.Without the actual devices involved our investigation cannot proceed.If the devices or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: GEN II RESURF PATELLA 41MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8610535
• Report Number: 1020279-2019-01946
• Device Sequence Number: 2523050
• Product Code: JWH
• UDI-Device Identifier: 03596010587596
• UDI-Public: 03596010587596
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2019

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 Expiration Date: 10/26/2020
• Device Catalogue Number: 71926226
• Device Lot Number: 10KM19838
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 10/04/2019
• 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: Hospitalization; Required Intervention