MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II 7.5MM RESUR PAT 32MM; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Model Number	71932636
Medical Device Problem Codes	Fracture (1260); Loss of Osseointegration (2408)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/06/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patella fracture, loosening of patella component, and dislocation were diagnosed.On (b)(6) 2019, the initial surgery was performed.On an unknown date, the patella was fractured.And the patella component was loose and disassociated.Revision surgery will be performed on (b)(6) 2020.After surgery, the component will be returned.
Event or Problem Description
It was reported that patella fracture, loosening of patella component, and dislocation were diagnosed.On (b)(6) 2019, the initial surgery was performed.On an unknown date, the patella was fractured.And the patella component was loose and disassociated.Revision surgery was performed on (b)(6) 2020, where the patella and insert were revised.
Additional Manufacturer Narrative
Section b5 and d11 were updated.
Additional Manufacturer Narrative
Event description (b5) and explantation date (d7) were received and updated.
Event or Problem Description
It was reported that patella fracture, loosening of patella component, and dislocation were diagnosed.On (b)(6) 2019, the initial surgery was performed.On an unknown date, the patella was fractured.And the patella component was loose and disassociated.Revision surgery was performed on (b)(6) 2020.

• Brand Name: GEN II 7.5MM RESUR PAT 32MM
• Common Device Name: PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9577165
• Report Number: 1020279-2020-00187
• Device Sequence Number: 2224317
• Product Code: JWH
• UDI-Device Identifier: 00885556056721
• UDI-Public: 00885556056721
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• 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): 02/27/2020

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 Model Number: 71932636
• Device Catalogue Number: 71932636
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 01/21/2020; 02/03/2020
• Initial Report FDA Received Date: 01/10/2020
• Supplement Report FDA Received Date: 01/24/2020; 02/27/2020
• 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: 74027262,13KM04293,JIIBCS XLE AT IST SZ 5-6 LT10MM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR