MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN POROUS CR FEM SZ 8L; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	71423248
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Ankylosis (4527)
Date of Event	06/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference case: (b)(4).
Event or Problem Description
It was reported that, after left tka system was placed on an unknown date in a patient with pre-existing stiffness and 5 degree flexion contracture due to left knee varus deformity, the patient started to suffer of ankylosis on his left knee.He presented issues getting an adequate range of motion following his left tka.In addition, the patient continued experiencing a 5 degree flexion contracture, but was able to flex to 80 degree.These complications were treated scheduling an additional surgery.The patient outcome is ongoing.
Additional Manufacturer Narrative
Section h3, h6: given the nature of the alleged incident, the device could not be returned for evaluation; therefore, a device analysis could not be performed.However, based on the information provided, the unsatisfactory experience could be confirmed.The clinical/medical investigation concluded that, per complaint details, approximately two months post left total knee arthroplasty, the patient had a manipulation under anesthesia as adequate range of motion was not achieved due to a diagnosis of ankylosis of the knee.A review of the provided case report forms indicated that the reported event is not related to the study device, but is an anticipated event that is possibly related to the procedure.Per complaint details, the 5 degree flexion contracture was due to a varus deformity that was present before implantation.The patient impact beyond that which has already been reported cannot be determined.However, it has been reported that the patient outcome is resolved.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 provides complete guidelines of indications, contraindications, warnings and precautions and possible adverse effects that may occur preoperative, during surgery or post operative.A review of the risk management file is not applicable because no information was provided that relates the failure mode to the device.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 specifications at the time of manufacture.Factors that could contribute to the reported event include procedural/user error and pre-existing patient condition.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.
Additional Manufacturer Narrative
H10 ¿ additional information: b7-other relevant history.D4- expiration date, unique identifier (udi) #.D6a- if implanted, give date.D10- concomitant medical products.G4- pma/510(k)number h11 ¿ corrected data.B5- describe event or problem.D1/d2a/d2b- brand name, product code, common device name.D4- catalog number, lot number.H6- evaluation codes: clinical and impact code.
Event or Problem Description
It was reported that, after a left tka surgery was performed on (b)(6) 2023, in which a lgn porous cr fem sz 8l was implanted in a patient with pre-existing stiffness and 5 degree flexion contracture due to left knee varus deformity, the patient started to suffer of ankylosis on his left knee on (b)(6) 2023.He presented issues getting an adequate range of motion following his left tka.In addition, the patient continued experiencing a 5 degree flexion contracture, but was able to flex to 80 degree.These complications were treated scheduling an additional surgery.The additional surgery was performed on (b)(6) 2023, but the implant was not removed.The surgeon did manipulation under anesthesia.The patient outcome is resolved.

• Brand Name: LGN POROUS CR FEM SZ 8L
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: 17218403
• Report Number: 1020279-2023-01381
• Device Sequence Number: 19482514
• Product Code: MBH
• UDI-Device Identifier: 00885556030684
• UDI-Public: 00885556030684
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K073325
• 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): 07/31/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71423248
• Device Lot Number: 22BTX0011P
• 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: 06/12/2023
• Supplement Date Received by Manufacturer: 06/28/2023; 07/28/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 07/26/2023; 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: GN XLP INS SZ 7-8 10MM(PN:71425355,LN:21LM08930); PRS OVL PTLL SZ 41MM(PN:74027441,LN:22FM20383); PRS TIB BSPLT SZ8 LT(PN:71425328,LN:22FM20278)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 106 KG