MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OVAL RESURFACING PAT 29MM; PROSTHESIS KNEE PATELLOFEMOROTIBIAL SEMI-CONSTRAINED CEMENTED POLY/METAL/POLY

Catalog Number	71421029
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a manipulation under anesthesia was performed on the patient due to increased pain and reduced range of motion.No instability identified, procedure completed successfully.
Additional Manufacturer Narrative
The associated genesis ii oval resurfacing patellar component, genesis ii long stem, journey tibial baseplate, journey ii bcs femoral component and journey ii articular insert were not returned for evaluation.A clinical evaluation noted that based on the information provided the root cause of poor range of the motion, multiple fall history, and the left knee arthrofibrosis could not definitively be determined.However, the reported non-compliance, chronic opiod usage, morbid obesity, and fall history cannot be ruled out as contributory factors to the reported issues.The future impact to the patient cannot be determined.No further clinical/medical assessment is warranted at this time.Our investigation including a review of the manufacturing records for the listed parts with 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.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: GII OVAL RESURFACING PAT 29MM
• Common Device Name: PROSTHESIS KNEE PATELLOFEMOROTIBIAL SEMI-CONSTRAINED CEMENTED POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8197913
• Report Number: 1020279-2018-02904
• Device Sequence Number: 13886335
• Product Code: JWH
• UDI-Device Identifier: 03596010485052
• UDI-Public: 03596010485052
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2019

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: 71421029
• Device Lot Number: 17KM02192
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 04/14/2019
• 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: Required Intervention
• Patient Age: 50 YR