MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MOD PF REVISION STEM 240MM SZ 13; PROSTHESISHIPSEMICONSTRAINEDUNCMNTDMETALPOLYMERNONPOROUSCALICUMPHOSPHAT

Model Number	71354313
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/22/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a dislocation of the stem.Previously, a closed reduction was attempted but was unsuccessful.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that, without the requested clinical information, a thorough medical investigation cannot be rendered.Should any additional medical information be provided this complaint will be re-assessed.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.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 risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes for this event could include poor surgical technique or device selection.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the devices or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: MOD PF REVISION STEM 240MM SZ 13
• Common Device Name: PROSTHESISHIPSEMICONSTRAINEDUNCMNTDMETALPOLYMERNONPOROUSCALICUMPHOSPHAT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9671380
• Report Number: 1020279-2020-00482
• Device Sequence Number: 2913538
• Product Code: MEH
• UDI-Device Identifier: 00885556210444
• UDI-Public: 00885556210444
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2020

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 Model Number: 71354313
• Device Catalogue Number: 71354313
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PART NUMBER: 71352112 / LOT NUMBER: UNKNOWN.; PART NUMBER: UNKNOWN / LOT NUMBER: UNKNOWN.; PART NUMBER: 71352112 / LOT NUMBER: UNKNOWN; PART NUMBER: UNKNOWN / LOT NUMBER: UNKNOWN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 96