MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOUR AR ISR TR BCS STD7-8 RT10; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	74033272
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Limited Mobility Of The Implanted Joint (2671)
Date of Event	08/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to instability.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical medical team concluded, no clinical relevant documents were provided to conduct a thorough medical assessment.No medical assessment is warranted at this time.This complaint will be re-evaluated if more information becomes available.Without the actual products involved, our investigation cannot proceed.Reviewing the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: JOUR AR ISR TR BCS STD7-8 RT10
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7856162
• Report Number: 1020279-2018-01750
• Device Sequence Number: 1986808
• Product Code: MDM
• UDI-Device Identifier: 03596010558718
• UDI-Public: 03596010558718
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2018

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: 74033272
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 09/07/2018
• Supplement Report FDA Received Date: 11/22/2018
• 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