MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII CONV W/TAPER SZ 6 RT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71420622
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Arthralgia (2355); Osteolysis (2377); Joint Laxity (4526); Metal Related Pathology (4530)
Date of Event	01/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a tka surgery had been performed on an unspecified date, the knee became symptomatic since, at least, 2020.About three weeks ago, a cracking noise was heard, so a radiological image was taken to check if an implant fractured.A revision surgery was conducted on (b)(6) 2022 to address the fracture of gii conv w/taper sz 6 rt.The total knee endoprosthesis was explanted: bone defects and massive metallosis were found intra-operatively; extraction of stem was only possible with bone fenestration.A spacer was implanted so reimplantation surgery is still pending.Patient current health status is not known.
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
It was reported that, after a right tka surgery had been performed on (b)(6) 2013, the knee became symptomatic since, at least, 2019.About three weeks ago, a cracking noise was heard, so a radiological image was taken to check if an implant fractured.A revision surgery was conducted on (b)(6) 2022 to address the fracture of gii conv w/taper sz 6 rt.The total knee endoprosthesis was explanted: bone defects and massive metallosis were found intra-operatively; extraction of stem was only possible with bone fenestration.A 2-stage revision surgery was performed, and the patient tolerated well the procedure.Patient current health status is not known.
Additional Manufacturer Narrative
Results of investigation: the device was not returned for evaluation but the pictures were reviewed, and the fracture was confirmed.The clinical/medical investigation concluded that, based documentation provided, the noted bone defects, osteolysis, laxity/instability & hesitant (delayed) treatment could not be ruled out as potential contributing factors to the reported cone fracture, severity of symptoms, & subsequent 2-stage tka revision, as patient was symptomatic prior to arthroscopies: aug.2019 when ¿metallose cannot be detected¿, as well as in 2020 w/¿no indication of prosthesis loosening¿.Post 2nd-stage revision histopathology supports fibrosed connective tissue with abundant black foreign material w/scattered 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 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.Some potential probable causes for this event could include but not limited to surgical technique, patient condition, overuse or excessive pressure on the joint.The contribution of the device to the reported incident could be corroborated as the device was broken and it was required a revision surgery.Based on this investigation, the need for corrective action is not indicated.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: GII CONV W/TAPER SZ 6 RT
• 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: 13700152
• Report Number: 1020279-2022-01070
• Device Sequence Number: 15072205
• Product Code: JWH
• UDI-Device Identifier: 03596010208538
• UDI-Public: 3596010208538
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K953274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2022

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: 10/05/2021
• Device Catalogue Number: 71420622
• Device Lot Number: 10KAF0020A
• 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: 02/17/2022
• Supplement Date Received by Manufacturer: 03/08/2022; 04/21/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 03/22/2022; 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2011
• 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: GII LNG STEM 14MM X 100MM-10EM09392; GII LNG STEM 18MM X 150MM-11KSM0008A; GNS II C/R FEM SIZE 6 RIGHT-13DM14901; GNS II NON-POR TIB SZ 7 RIGHT-13GT32378
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male