MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 7-8 RT 9; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Catalog Number	74023271
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed to exchange insert due to unspecified damage.
Additional Manufacturer Narrative
The associated journey articular insert was not returned for evaluation.The device was manufactured in 2009.Our investigation including a review of the complaint history for the listed part revealed no prior complaints for the listed failure mode.The batch number was provided for the device.Thus, a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.Our clinical evaluation noted that no clinical relevant documents were provided to conduct a thorough medical assessment.No medical assessment is warranted at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is 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: JOURN ART INS BCS STD 7-8 RT 9
• 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: 8207390
• Report Number: 1020279-2019-00001
• Device Sequence Number: 16650573
• Product Code: JWH
• UDI-Device Identifier: 03596010555274
• UDI-Public: 03596010555274
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2019

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 Expiration Date: 06/30/2019
• Device Catalogue Number: 74023271
• Device Lot Number: 09FM01935
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 01/01/2019
• Supplement Report FDA Received Date: 04/02/2019
• 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: Hospitalization; Required Intervention