MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CEM TIB SIZE 8 RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71420191
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).
Event or Problem Description
It was reported that, after a tka, it was detected that a gns ii cem tib size 8 right (71420191) was implanted with a jrny ii cr fem ox np rt sz 8 (74021158) and a jii md xlpe art isrt sz 7-8 rt 11mm (74021483) on a patient.Genesis and journey implants are not compatible.It is unknown if this has caused any issue to the patient.
Event or Problem Description
It was reported that, after a tka surgery was performed on (b)(6) 2023, it was detected that a gns ii cem tib size 8 right (71420191) was implanted with a jrny ii cr fem ox np rt sz 8 (74021158) and a jii md xlpe art isrt sz 7-8 rt 11mm (74021483) on a patient.Genesis and journey implants are not compatible.No issue was noticed intra-operatively when locking the insert into the baseplate.The surgeon attributes this incident to the following factors: (i) an incorrect product was on the shelf when it should not have been, and (ii) the product labeling between genesis ii and journey ii baseplates is far too similar.It is unknown if this has caused any issue to the patient.
Additional Manufacturer Narrative
Describe event or problem.
Additional Manufacturer Narrative
Given the nature of the alleged incident, the device was not returned for evaluation.A review made by the engineering team revealed that the laboratory results of mismatch testing using an insert with a tibial base of different systems (journey ii sz 7-8 insert on a genesis ii sz 7 tibial base) indicated a lower locking strength than when implants of the same system are used ( journey ii sz 7-8 insert on journey ii sz 8 tibial base).In addition, there is a transition to update the label legibility format which standardizes the information on the box end panel, with key information called out in specific areas for assistance in identification.The clinical/medical investigation concluded that, reportedly, there was no issue with locking the insert into the baseplate intraoperatively.It was noted via e-mail correspondence that the billing team was the first to notice the error as the construct was not aligning with the implants used.Additionally, it was reported that journey ii components were the only components that should have been on the shelves.It was communicated that the patient has not experienced any symptoms or adverse as of yet.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.A review of the production order 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 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 instructions for use documents for knee systems revealed in indications, contraindications, and adverse effects that preoperative planning and meticulous surgical technique are essential to achieve optimum results.In the preoperative warnings and precautions it is indicated that an adequate inventory of implant sizes should be available at the time of surgery.Besides, it indicates that each total knee system is designed as a system and does not allow the substitution of components from other systems or manufacturers.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 evidence to conclude that the product failed to meet any specifications at the time of manufacture.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.We consider this investigation closed.

• Brand Name: GNS II CEM TIB SIZE 8 RIGHT
• 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: 18212887
• Report Number: 1020279-2023-02332
• Device Sequence Number: 7345591
• Product Code: JWH
• UDI-Device Identifier: 03596010206381
• UDI-Public: 03596010206381
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71420191
• Device Lot Number: H2143035
• 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: 11/06/2023
• Supplement Date Received by Manufacturer: 11/29/2023; 02/23/2024
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 11/30/2023; 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2021
• 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: JRN II CR FEM OX SZ8RT(PN:74021158,LN:21CM04371).; JRN II INS SZ7-8RT11MM(PN:74021483,LN:21MM01084).
• Patient Age: 72 YR
• Patient Sex: Male