MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS INSERT SZ 5-6 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420832
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Case- (b)(4).
Event or Problem Description
It was reported that, a revision of a gen 2 tibia from approximately 2010 was performed.The tibia insert was loose and removed with fingers and revised to a legion revision tibia with stem.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to loosening.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record review cannot be completed.There is no information that would suggest the device failed to meet specifications.Based on this investigation, the need for corrective action is not indicated.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.A medical analysis noted that a single undated x-ray was provided and reviewed.The x-ray supports the reported event, but no further information can be concluded as to the root cause.Therefore, the patient impact beyond the revision cannot be determined.Due to the limited information provided, no further clinical assessment is warranted.Some potential causes could include but are not limited to fit/sizing, traumatic injury, abnormal motion over time or patient medical history.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: GII PS INSERT SZ 5-6 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11023501
• Report Number: 1020279-2020-07543
• Device Sequence Number: 4242161
• Product Code: JWH
• UDI-Device Identifier: 03596010209658
• UDI-Public: 03596010209658
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71420832
• Device Catalogue Number: 71420832
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 03/03/2021
• 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: Required Intervention