MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OVAL RESURFACING PAT 32MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71421032
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/17/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
Remaining loss of function and limited flexion and extension after tka left.Subject was hospitalised and underwent manipulation under anesthesia.
Additional Manufacturer Narrative
The associated journey ii bcs oxinium femoral component, journey ii bcs articular insert, journey tibia baseplate and genesis ii oval resurfacing patellar were not revised and are not being returned for evaluation.It was reported that the patient underwent manipulation under anesthesia (mua).The reason for this action was most likely necessary to improve the patients range of motion.The process will break-up the scar tissue, fibrous materials and adhesions that are causing stiffness in the joint, improving the range of motion in the patient.Anesthesia or sedation was most likely used to reduce pain and spasms.An mua is an accepted treatment for certain isolated joint conditions, such as arthrofibrosis of the knee.Therefore, a device analysis was not required.Product details were provided, so our investigation included the manufacturing records and complaint history review.The review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.A clinical analysis could not be performed as requested supporting clinical/medical documents were not provided.Thus, a thorough evaluation could not be performed.Should additional relevant clinical information become available this complaint will be re-assessed.Without the return of the actual product involved or clinical/medical documents, our investigation of this report is inconclusive.No further investigation warranted for this complaint; and smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened and reevaluated.We consider this investigation closed.

• Brand Name: GII OVAL RESURFACING PAT 32MM
• 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: 8395663
• Report Number: 1020279-2019-00930
• Device Sequence Number: 1288584
• Product Code: JWH
• UDI-Device Identifier: 03596010485069
• UDI-Public: 03596010485069
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2019

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 Catalogue Number: 71421032
• Device Lot Number: 14BM03047
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 06/13/2019
• 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
• Patient Age: 51 YR