MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. JRNY BCS PAT RESRF RD 35 MM STD; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74024835
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	08/29/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2017 doctor elected to aspirate 10cc of blood-tinged fluid on from patient's knee joint, 12 days later doctor injected 20.5mci of tc 99m hdp due to pain and swelling.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.A review of complaint history revealed no prior complaints for the listed lots.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.Our clinical/medical team concluded, based on the available information; the root cause of the ¿effusions and instability¿ cannot be concluded.It is unknown if the ¿scar tissue¿ or if the needed larger insert contributed to the issues.A causal relationship of the prosthesis to the ¿effusions and instability¿ has not been demonstrated at this time.Also reported was a fall ¿at work¿ post-revision; she was taken to the hospital from ¿the stadium¿.This event reportedly slowed down her recovery from the revision.No other follow up information was provided at this time.Without the actual product involved, our investigation cannot proceed.If the devices or new information is received in the future, these complaints can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: JRNY BCS PAT RESRF RD 35 MM STD
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis, tennessee; memphis 38116
• MDR Report Key: 7934930
• Report Number: 1020279-2018-02108
• Device Sequence Number: 11211935
• Product Code: JWH
• UDI-Device Identifier: 03596010554543
• UDI-Public: 03596010554543
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2018

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: 03/28/2024
• Device Catalogue Number: 74024835
• Device Lot Number: 14CM22310
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 12/06/2018
• 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: Other; Required Intervention