MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II CEMENTED TIBIAL B/PLATE SZ 3 LEFT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71420164
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/13/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a manipulation under anesthesia due to arthrofibrosis on the left knee.
Additional Manufacturer Narrative
It was reported that the patient was hospitalized and treated with an unspecified non-invasive procedure due to arthrofibrosis on the left knee.The affected legion oxinium femoral component, genesis ii resurfacing patellar component, genesis ii deep flexion insert and genesis ii tibial baseplate were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.A clinical evaluation noted that an arthrofibrosis is a complication that can occur after surgery where an excessive scar tissue response leads to painful restriction of joint motion.The reason for the mua was not due to a failure of the smith and nephew device.It has been communicated that the mua has resolved the issue experienced by the patient.No further clinical/medical assessment is warranted at this time.No further investigation warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: GEN II CEMENTED TIBIAL B/PLATE SZ 3 LEFT
• 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: 8931583
• Report Number: 1020279-2019-03198
• Device Sequence Number: 1948349
• Product Code: JWH
• UDI-Device Identifier: 03596010206251
• UDI-Public: 03596010206251
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2019

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: 71420164
• Device Lot Number: 12DT17424
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 11/12/2019
• 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 Weight: 100