MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II 7.5MM RESUR PAT 35MM; PROSTHE, KNEE, PATELLOFEMO, SEMI-CONS, CEMENTED, POLY/METAL/POLY

Model Number	71932637
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent revision surgery to explant a patella due to loosening.Insert was also explanted.
Additional Manufacturer Narrative
The device, used in treatment were not returned for evaluation, reporting event could not be confirmed.A clinical evaluation was conducted and confirms that without the requested clinical information a thorough medical investigation cannot be rendered.Should any additional clinical information be provided this complaint will be re-evaluated.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.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 complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the risk management file and instructions for use document for this failure mode was conducted.Factors and/or potential causes that could contribute to the reported event have been identified in the risk management file, include but not limited to abnormal motion over time, bone degeneration fit/sizing, lack of ingrowth and traumatic injury.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: GEN II 7.5MM RESUR PAT 35MM
• Common Device Name: PROSTHE, KNEE, PATELLOFEMO, SEMI-CONS, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9413594
• Report Number: 1020279-2019-04284
• Device Sequence Number: 4220690
• Product Code: JWH
• UDI-Device Identifier: 00885556057117
• UDI-Public: 00885556057117
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2020

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: 71932637
• Device Catalogue Number: 71932637
• Device Lot Number: 17HM09512
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 04/23/2020
• 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