MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II BICONVEX PAT 23MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420566
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Muscle Weakness/Atrophy (1967); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Arthralgia (2355); Implant Pain (4561); Insufficient Information (4580)
Date of Event	06/07/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
*us legal mdl* plaintiff underwent medically-indicated revision surgery on (b)(6) 2014 on an unspecified knee side due to unspecified reasons.It is unknown which devices were explanted during the procedure.The primary tkr was performed on (b)(6) 2019.The outcome of the patient is unknown.
Additional Manufacturer Narrative
H11.Corrected information in b3, b5 and h6 (health effect - clinical code).Internal reference number: (b)(4).
Event or Problem Description
Plaintiff underwent medically-indicated revision surgery of the left knee on (b)(6) 2019 due to chronic pain, which the patient presented since (b)(6) 2017.During this procedure, the patellar component and the insert were exchanged.The primary tkr was performed on (b)(6) 2014.The outcome of the patient is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, without the requested documentation, the clinical root cause of the reported event could not be fully assessed nor concluded.The patient impact beyond the reported chronic pain and revision could not be determined.No further medical assessment could be rendered at this time.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 similar events for the listed device.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction or loss of sterility.The contribution of the device to the reported event could not be corroborated.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.
Event or Problem Description
Plaintiff underwent medically-indicated revision surgery of the left knee on (b)(6) 2019 due to chronic pain and limited range of motion of about 90 degrees presented since (b)(6) 2015.During this procedure, the patellar component and the polyethylene insert were exchanged.The primary tkr was performed on (b)(6) 2014.The patient tolerated the procedure well and left the operating room in satisfactory condition.
Additional Manufacturer Narrative
The device 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 could not be definitively concluded; however, the revision findings of ¿large amount scar removed from medial & lateral gutters¿ bone spurs and excessive bone growth over patella¿ are likely contributing factors.Scar formation and ossification are both known occurrences post-tka and neither are indicative of component malperformance.Additionally, the poly was upsized, as well, which could indicate joint laxity had occurred.The assessed patient impact was the reported pain, reduced rom, scar formation, ossifications and subsequent interventions including pt, medications, and eventual revision.Reportedly, the patient continues to have complaints of chronic symptoms but declined further surgical intervention for the left knee.Of note, the revision resulted in an off-label/mixed manufacturer construct.No further medical assessment can be rendered at this time.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 similar events for the listed device.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction or loss of sterility.The contribution of the device to the reported event could not be corroborated.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: GNS II BICONVEX PAT 23MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12595380
• Report Number: 1020279-2021-07467
• Device Sequence Number: 4523075
• Product Code: JWH
• UDI-Device Identifier: 03596010208255
• UDI-Public: 03596010208255
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/28/2022

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 Expiration Date: 01/14/2024
• Device Model Number: 71420566
• Device Catalogue Number: 71420566
• Device Lot Number: 14AM12668
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 12/08/2021; 02/16/2022; 04/27/2022; 06/24/2022
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 12/15/2021; 02/17/2022; 05/11/2022; 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 77 YR
• Patient Sex: Female