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 legion insert was returned and evaluated.The patella was not returned for evaluation.A visual examination of the insert indicated the post has fractured off, the fractured off portion was not.The insert had some discoloration to the face with deep surface markings on the articulating surface, with some pits.There is some damage to the locking detail.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incidents.A lab analysis indicated that based on these results, the cause of this fracture appears to be repeated posterior impingement of the femoral cam on the ps post.The resultant damage on the posterior face of the ps post likely created a stress concentration that initiated one or more fatigue cracks, which propagated in an anterior direction until final fracture occurred.Our clinical team has concluded 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.Based on the information provided the patient¿s morbid obesity weight of (b)(6) lbs, 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.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.

• 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: 8610534
• Report Number: 1020279-2019-01944
• Device Sequence Number: 11263544
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2019

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: 11/10/2019
• 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