MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 3-4 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71453113
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	07/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after tka had been performed on unspecified date, the patient experienced wound breakdown.This adverse event was treated on (b)(6) 2021 with knee debridement and washout.Additionally, the lgn cr high flex xlpe sz 3-4 13mm was exchange to lgn cr high flex xlpe sz 3-4 15mm, for prophylactic purposes.Patient current health status is unknown.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, without the request clinical information, a thorough medical investigation cannot be rendered nor can the root cause of the reported wound breakdown be determined.Based on the limited information provided, this adverse was treated with a knee debridement and washout.In addition, the patient¿s lgn cr high flex xlpe sz 3-4 13mm was exchange to lgn cr high flex xlpe sz 3-4 15mm for prophylactic purposes.The impact to the patient beyond that which has already been reported is unknown.Should any additional medical information be provided, this compliant will be re-assessed.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 did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.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 could be patient anatomy/reaction, traumatic injury, procedural/user error or post-operative healing issue.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 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12236076
• Report Number: 1020279-2021-06062
• Device Sequence Number: 11671298
• Product Code: JWH
• UDI-Device Identifier: 00885556034538
• UDI-Public: 00885556034538
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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 Model Number: 71453113
• Device Catalogue Number: 71453113
• Device Lot Number: 18HM21505
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention