MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN XLPE PS INSERT SZ 5-6 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 71453252

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 11/15/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during a tka a lgn xlpe ps insert sz 5-6 9mm had a manufacturing problem.Surgeon attempted to implant the poly into the tibia baseplate with a total of 3 polys.I did product complaints on the first 2, while the 3rd was successfully implant.During the attempts to implant the first 2, neither poly seems to want to engage the tibia laterally.The surgeon attempted probably 5-10 times to implant both of the first 2 polys opened.After making more soft tissues releases than he normally would, he purposefully tried to engage laterally and eventually got it to engage.The surgeon said he thought there seemed to be an issue with the tibia baseplate laterally because it didn¿t want to engage the poly as it typically would.The procedure was resumed, after a non-significant delay, with a s+n back-up device.

Event Description

It was reported that, during a tka a lgn xlpe ps insert sz 5-6 9mm had a manufacturing problem.The surgeon attempted to implant the poly into the tibia baseplate but could not engage the tibia laterally.After making more soft tissues releases than he normally would, he purposefully tried to engage laterally and eventually got it to engage.The surgeon said he thought there seemed to be an issue with the tibia baseplate laterally because it didn¿t want to engage the poly as it typically would.The procedure was resumed, after a non-significant delay, with a s+n back-up device.

Manufacturer Narrative

H10: h3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed a similar event for the listed devices over the previous 12 months, but no similar events for the batches based on the historical data, 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 in indications, contraindications, and adverse effects that preoperative planning and meticulous surgical technique are essential to achieve optimum results.A review of the risk management files 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 these products and event.According with inspection drawing, the visual inspection includes the verification of part configuration per print.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.However, based on the information provided, the unsatisfactory experience could be confirmed.A factor that could contribute to the reported event include insertion technique.Based on this investigation, the need for corrective action is not indicated.Should the devices 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.H11: corrected data updated section b5 and h6 (impact code and medical device problem code).

• Brand Name: LGN XLPE PS INSERT SZ 5-6 9MM
• Type of Device: 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: 18312982
• MDR Text Key: 330301177
• Report Number: 1020279-2023-02485
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556255858
• UDI-Public: 00885556255858
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/15/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 71453252
• Device Lot Number: 23GM16710
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 01/12/2024
• Supplement Dates FDA Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention