MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II RESURF PATELLA 38MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIND, CEMENTD, POLY/METAL/POLY

Model Number	71926225
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Damage to Ligament(s) (1952); Joint Dislocation (2374)
Date of Event	10/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that primary procedure was performed in january this year.According to the surgeon, the patient dislocated the patella and had a quadriceps injury, requiring a medial patellofemoral ligament (mpfl) repair.The insert was removed and a smaller trial was inserted (21mm) to repair the mpfl.
Additional Manufacturer Narrative
It was reported that the patient dislocated the patella and had a quadriceps injury, requiring a medial patellofemoral ligament repair.The insert was removed and a smaller trial was inserted (21mm) to repair the mpfl.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Some potential causes of the reported event could include but are not limited to traumatic injury, patient anatomy or abnormal loading of limb.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: GEN II RESURF PATELLA 38MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIND, CEMENTD, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10841667
• Report Number: 1020279-2020-06466
• Device Sequence Number: 17064046
• Product Code: JWH
• UDI-Device Identifier: 00885556043998
• UDI-Public: 00885556043998
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2021

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 Model Number: 71926225
• Device Catalogue Number: 71926225
• Device Lot Number: 19AM03569
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 11/15/2020
• Supplement Report FDA Received Date: 03/09/2021
• 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