MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNSII CON INS SZ3-4 11MM; PROSTH,KNEE,PATFEMTIB,SEMCONSTR,CEMNT,POL/METL/POL

Model Number	71420524
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Damage to Ligament(s) (1952); Scar Tissue (2060); Injury (2348); Joint Laxity (4526)
Date of Event	08/31/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was perform on aug 31,2020 due to joint ligament laxity.The primary total knee arthroplasty procedure was approximately 10 years ago.No more information available.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, based on the documentation provided, the root cause of the reported event was most likely the reported overgrowth of bone along with ligament stretching which are both known potential complications post tka and could be seen in situations after years of use.The patient impact beyond the reported joint laxity/instability could not be determined, although the revision op note indicated ¿excellent stability, full rom without impingement¿ with the revision (15mm) poly.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as but not limited to abnormal motion over time, bone degeneration, fit/sizing, lack of ingrowth, lifetime of device, and traumatic injury.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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.We consider this investigation closed.

• Brand Name: GNSII CON INS SZ3-4 11MM
• Common Device Name: PROSTH,KNEE,PATFEMTIB,SEMCONSTR,CEMNT,POL/METL/POL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10591551
• Report Number: 1020279-2020-04901
• Device Sequence Number: 16746595
• Product Code: JWH
• UDI-Device Identifier: 03596010208040
• UDI-Public: 03596010208040
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

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: Lay User/Patient
• Device Model Number: 71420524
• Device Catalogue Number: 71420524
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 07/01/2021
• 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