MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 3-4 RT 9; PRSTHSS,KN,PTLLFMRTBL,SM-CNSTRND,CMNTD,PLYMR/MTL

Model Number	74023231
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient presents subluxation.Revision surgery is scheduled to be performed on (b)(6) 2020.
Additional Manufacturer Narrative
Results of investigation: the devices, used in treatment, was not returned for evaluation and the reported event could not be confirmed.Procedure was on hold due to covid-19 pandemic.The device was manufactured in 2006.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.Our clinical/medical team noted: without the requested relevant clinical information, a thorough medical investigation cannot be rendered.Per subsequent email, the revision ¿is now delayed¿.Therefore, no further clinical/medical assessment is warranted at this time.Should any additional medical information be provided this complaint would be re-assessed.A root cause could not be determined with the information provided.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JOURN ART INS BCS STD 3-4 RT 9
• Common Device Name: PRSTHSS,KN,PTLLFMRTBL,SM-CNSTRND,CMNTD,PLYMR/MTL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9702644
• Report Number: 1020279-2020-00527
• Device Sequence Number: 2362218
• Product Code: JWH
• UDI-Device Identifier: 03596010554994
• UDI-Public: 03596010554994
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2020

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: 07/28/2016
• Device Model Number: 74023231
• Device Catalogue Number: 74023231
• Device Lot Number: 06GM08258
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 11/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR