MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS INSERT SZ 7-8 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META

Model Number	71420844
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	07/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient fall while being at home, therefore revision surgery was necessary, during the revision surgery the genesis ii ps insert size 7-8 9mm was found to be broken.No other patient injury or other complications were reported.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.The lab analysis concluded that the as received component was visually inspected for signs of damage.The tibial insert showed signs of wear related damage to the articulating surface.The posterior edge region showed signs of wear and deformation.The post was fractured near the base of the post.Signs of deformation were observed on the anterior, posterior, medial, and lateral regions of the insert post.No material or manufacturing defects were observed during this investigation.The clinical/medical concluded that the two photos provided of the insert support the reported failure.However, per the attachment in the case notes, no further clinical information is available for this complaint.Without supporting clinical documentation, a thorough medical investigation cannot be rendered.Based on the information provided, the patient sustained a fall at home and underwent a revision that revealed a broken 7-8 9mm genesis ii ps insert.Since no other injury or complication were reported, no further clinical/medical assessment is warranted at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: GII PS INSERT SZ 7-8 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10435074
• Report Number: 1020279-2020-04117
• Device Sequence Number: 3446635
• Product Code: JWH
• UDI-Device Identifier: 03596010209719
• UDI-Public: 03596010209719
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2021

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: 71420844
• Device Catalogue Number: 71420844
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Initial Date Received by Manufacturer: 07/29/2020
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 09/03/2021
• 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: Hospitalization; Required Intervention
• Patient Weight: 191