MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 3.5MM PRXHUM LK PL 3H R 89MM; PLATE, FIXATION, BONE

Catalog Number	R71801303
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed because the implants were out of place.The problem was corrected placing a total shoulder prosthesis.The patient´s health condition is stable.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, based solely on the imaging provided, unable to rule out a malaligned reduction of the proximal humerus fracture and subsequent plate disassociation as a contributing factor to the reported ¿out of place¿ locking plate and subsequent revision.The patient impact beyond possible pain/discomfort and the revision procedure itself cannot be determined.No further medical assessment can be rendered at this time.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 part revealed no prior complaints for the listed batch.Without the actual product involved and/or device information 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: 3.5MM PRXHUM LK PL 3H R 89MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7225123
• Report Number: 1020279-2018-00089
• Device Sequence Number: 1485473
• Product Code: HRS
• UDI-Device Identifier: 03596010573544
• UDI-Public: 03596010573544
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K092015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/04/2018

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: 08/17/2025
• Device Catalogue Number: R71801303
• Device Lot Number: 15HM14042
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2018
• Supplement Date Received by Manufacturer: 01/17/2018; 01/17/2018
• Initial Report FDA Received Date: 01/29/2018
• Supplement Report FDA Received Date: 01/31/2018; 05/04/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 71 YR