MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II BICONVEX PAT 32MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420572
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
Us legal.It was reported that, after an tka surgery had been performed on (b)(6) 2008, the post of a gii ps hi flex isrt sz 5-6 11 broke, making the knee unstable.On (b)(6) 2020, an arthroscopy was performed to confirm post breakage.The insert was exchanged during a revision surgery on (b)(6) 2020.During surgery, the patella showed minimal wear and a patellar tibial tubercule pin was placed.The patient tolerated the procedure well and was then transported to the recovery room in good condition.
Additional Manufacturer Narrative
H3, h6: the device was not received for evaluation and the reported event could not be confirmed.The shipping information was provided and all efforts were made to locate the device but we have no evidence that it was ever received by the complaint investigation team for evaluation.The clinical/medical investigation concluded that, based on the information provided, the clinical root cause for the reported acute onset of pain, instability/luxation, and post-breakage and subsequent surgical procedures was mostly likely the ¿awkwardly twisting¿/ knee ¿torqueing¿ incident the patient reportedly experienced just prior to the (b)(6) 2020 office visit (approximately 12 years post implantation).The ifu does address the implant limitations (can break) and finite expected service life.The assessed patient impact was the reported signs/symptoms and subsequent surgical interventions.Further patient impact could not be determined.It was reported at the 6-week follow-up that the patient had ¿absolutely no discomfort¿ and was ¿quite pleased¿.No further medical assessment could 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 for the part number over the past 12 months and for the batch number based on historical data of the device 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.Potential causes could include but are not limited to friction, joint tightness or lifetime of device.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.(b)(4).

• Brand Name: GNS II BICONVEX PAT 32MM
• 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: 12602211
• Report Number: 1020279-2021-07487
• Device Sequence Number: 17007261
• Product Code: JWH
• UDI-Device Identifier: 03596010208286
• UDI-Public: 03596010208286
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/21/2018
• Device Model Number: 71420572
• Device Catalogue Number: 71420572
• Device Lot Number: 08EM18803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2021
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 10/09/2021
• Supplement Report FDA Received Date: 03/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2008
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 71420170-GNS II CMT TIB SIZE 6 LEFT; 71421017-GII OXIN P/S FEM LT SZ 7
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Age: 69 YR
• Patient Sex: Male