MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II 7.5MM RESUR PAT 32MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR

Catalog Number	71932636
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/05/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a local antiseptic injection of lidocaine and marcaine and a joint aspiration was required due to postoperative increasing pain.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.The following are the results of our investigation: the associated complaint devices were not returned.The clinical/medical team concluded, r/t (b)(4).This is a journey ii bcs retro subject#: (b)(4).Original date of surgery was (b)(6) 2015.Approximately 15 months later ae#: 11 event: status post right knee arthroplasty revision with increasing pain occurred.This event was classified as moderate in severity, possible related to the procedure and the device.The crf provided have been reviewed, however, no clinical supportive documents have been provided.According to the operating surgeon, he performed a local antiseptic injection of lidocaine and marcaine and a joint aspiration that was sent for culture on (b)(6) 2016.The injection provided transient and minor relief.The culture was negative for bacterial growth.Steroid injection was given on (b)(6) 2016 of depo-medrol.On (b)(6) 2016 mri of lumbar spine was ordered and showed significant degeneration in the lumbar spine.On (b)(6) 2016 surgeon repeated joint aspiration for culture and ordered a bone scan.Neither results of the cultures nor has bone scan been provided.Since the device remains in situ, and no clinical information will be provided, we are unable to determine the root cause of the reported pain.The future impact to the patient is unknown since this ae has not resolved.No further clinical/medical assessment is warranted at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.

• Brand Name: GEN II 7.5MM RESUR PAT 32MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7164285
• Report Number: 1020279-2018-00022
• Device Sequence Number: 16638982
• Product Code: JWH
• UDI-Device Identifier: 00885556056721
• UDI-Public: 00885556056721
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2018

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: 09/23/2024
• Device Catalogue Number: 71932636
• Device Lot Number: 14JM19043
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2017
• Supplement Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 04/19/2018
• 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
• Patient Age: 60 YR