MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII CR DEEP FLEX ISRT S3-4 13M; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71421538
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/02/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was noted with stiffness post left tkr for which manipulation under anesthesia was required.
Additional Manufacturer Narrative
It was reported that the clinical study patient was noted with stiffness post left tkr for which manipulation under anesthesia was required.The affected legion oxinium femoral component, genesis ii resurfacing patellar component, genesis ii cr 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.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Without the return of the actual product involved and no patient records available, our investigation of this report is inconclusive.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: GII CR DEEP FLEX ISRT S3-4 13M
• 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: 9060665
• Report Number: 1020279-2019-03364
• Device Sequence Number: 3173869
• Product Code: JWH
• UDI-Device Identifier: 03596010512468
• UDI-Public: 03596010512468
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K041825
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2019

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 Expiration Date: 09/19/2021
• Device Catalogue Number: 71421538
• Device Lot Number: 11JM11728
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 09/15/2019
• Supplement Report FDA Received Date: 12/11/2019
• 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: 80 YR
• Patient Weight: 75