MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II ISRT XLPE DD LT SZ 1-2 9MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	74025721
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/30/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient suffered a contracture on the left knee.The event was treated via manipulation under anesthesia.
Additional Manufacturer Narrative
The devices, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The devices were manufactured in 2015, 2016 and 2017.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the risk management file and instructions for use document for this failure mode was conducted and concluded this failure mode has been identified.Our clinical/medical team noted: it was reported that a clinical study patient experienced a moderately severe left knee contracture (ae#1) approximately 5½ weeks post left tka.Per crfs, an mua was performed approximately 8 weeks post implantation.Per the provided crfs, the contracture was possibly related to the device and/or surgery.No further clinically relevant medical documentation was provided; therefore, a thorough medical investigation could not be performed.Although the root cause could not be concluded, adhesions and/or limited rom are known potential complications s/p tka.The patient impact beyond the reported contracture and subsequent mua could not be determined, as the patient status was reportedly ¿unknown¿.Should clinical documentation become available in the future, the clinical/medical task may be re-evaluated.No further medical assessment is warranted at this time.A definite root cause could not be determined.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.

• Brand Name: JRNY II ISRT XLPE DD LT SZ 1-2 9MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9842212
• Report Number: 1020279-2020-00907
• Device Sequence Number: 19014599
• Product Code: JWH
• UDI-Device Identifier: 00885556096819
• UDI-Public: 00885556096819
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 74025721
• Device Catalogue Number: 74025721
• Device Lot Number: 17BM02686
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 11/13/2020
• 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