MAUDE Adverse Event Report: SMITH & NEPHEW, INC. IT WAS REPORTED THAT PATIENT HAD A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFI; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Catalog Number	71421035
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/24/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had a manipulation under anesthesia due to arthrofibrosis to relieve joint immobilization.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, this is a complaint submitted by the (b)(6) study, reporting adverse event 1 for subject (b)(6).The primary surgery was performed in (b)(6) 2018.Adverse event 1 occurred in (b)(6) 2018.It was documented as arthrofibrosis that required a "manipulation under anesthesia" to improve range of motion.The device remains insitu and the subject continues in the study.Several attempts have been made to obtain clinical/medical documents to no avail.Without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.A review of the production documentation for the corresponding products 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 batches.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.We consider this investigation closed.

• Brand Name: IT WAS REPORTED THAT PATIENT HAD A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFI
• Common Device Name: PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7697384
• Report Number: 1020279-2018-01319
• Device Sequence Number: 1329258
• Product Code: JWH
• UDI-Device Identifier: 03596010485076
• UDI-Public: 03596010485076
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2018

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 Catalogue Number: 71421035
• Device Lot Number: 17LM19543
• Initial Date Received by Manufacturer: 06/24/2018
• Supplement Date Received by Manufacturer: 06/24/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 09/16/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR