MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 7-8 9MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER

Model Number 71453231

Device Problems Material Erosion (1214); Material Integrity Problem (2978)

Patient Problem Failure of Implant (1924)

Event Date 09/26/2022

Event Type  Injury  

Event Description

It was reported that, during a tka revision surgery performed on (b)(6) 2022, a lgn ps high flex xlpe sz 7-8 9mm was explanted and its post was noticed to be "melted".Additional details related to this procedure are unknown at this moment.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

B5 (event description), h6 (medical device problem).B1.

Event Description

It was reported that, during a tka revision surgery performed on (b)(6) 2022, a lgn ps high flex xlpe sz 7-8 9mm was explanted and its post was noticed to be degraded.Additional details related to this procedure are unknown at this moment.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation but the pictures were reviewed, and revealed that the post was noticed to be degraded.The clinical/medical investigation concluded that, per the complaint details, a revision was performed due to unspecified reason(s) and the explanted cross-linked polyethylene ¿post was noticed to be melted¿.Correspondence reported ¿the post degraded.The surgeon was not able to find a broken piece of the post inside of the patient's knee¿.Although the primary implantation date is unknown, the manufacture date of the cross-linked polyethylene appears to have been 06-aug-2008 indicating the maximum possible length of time in-vivo of the component would be approximately 14 years.It was communicated that the clinical documentation was not available; therefore, no contributing clinical factors could be definitively concluded, and it is unknown if there was a possible retained foreign body or if the reported component degradation was from age-related wear as there was no report of debris within the joint space.The patient impact beyond the reported revision and findings of the ¿melted¿ post cannot be determined.No further medical assessment can be rendered at this time.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 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 instructions for use documents for knee systems revealed that wear of the polyethylene articulating surfaces of knee replacement components has been reported following total knee replacement.Higher rates of wear may be initiated by particles of cement, metal, or other debris which can cause abrasion of the articulating surfaces.Higher rates of wear may shorten the useful life of the prosthesis, and lead to early revision surgery to replace the worn prosthetic components, this has 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.Factors that could contribute to the reported event include friction or joint tightness.The contribution of the device to the reported event could be corroborated as the post was noticed to be degraded and explanted.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: LGN PS HIGH FLEX XLPE SZ 7-8 9MM
• Type of Device: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER
• 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: 15715030
• MDR Text Key: 302854558
• Report Number: 1020279-2022-04645
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556034620
• UDI-Public: 00885556034620
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/23/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2018
• Device Model Number: 71453231
• Device Catalogue Number: 71453231
• Device Lot Number: 08HM04101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/07/2022
• Initial Date FDA Received: 11/02/2022
• Supplement Dates Manufacturer Received: 10/07/2022; 12/22/2022
• Supplement Dates FDA Received: 11/30/2022; 12/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2008
• 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