MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 3-4 10MM; PROSTHESIS, KNEE, PATELLOFEM, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Model Number 71453183

Device Problem Biocompatibility (2886)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930)

Event Date 12/10/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference number: (b)(4).

Event Description

It was reported that, after a tka surgery had been performed in (b)(6) 2016 with a legion porous system, patient felt left knee hematogenous infection.A left knee incision and drainage with revision of articular surfaces treatment was performed to resolve the reported event.

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 the requested clinical documentation has not been provided as of the date of this medical investigation; however, it was reported that the aemb cannot exclude the contribution of the device to the infection.The event occurrence date was reportedly (b)(6) 2021 with a status of ¿resolved¿.Without the requested clinical documentation, the root cause of the reported event could not be further assessed.The patient impact beyond the reported infection, i&d and articular insert revision could not be determined.No further medical assessment could be rendered at this time.A review of complaint history of the previous 12 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for knee systems revealed that acute post-surgical wound infection and late deep wound sepsis have been identified as possible adverse effects.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.Possible causes could include but are not limited to contamination, patient reaction, and post-operative healing issue.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: LGN CR HIGH FLEX XLPE SZ 3-4 10MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEM, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
• 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: 14490594
• MDR Text Key: 292611302
• Report Number: 1020279-2022-02569
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556487341
• UDI-Public: 00885556487341
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71453183
• Device Catalogue Number: 71453183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GEN II 7.5MM RESUR PAT 32MM; GNS II CMT TIB SIZE 4 LEFT; LEGION NARROW CR OXIN SZ 6N LT
• Patient Outcome(s): Required Intervention; Hospitalization