MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF SPHER HEAD SCREW 30MM; PROSTHSIS, HIP, SMI-CONSTRAIND, UNCMNTD, MTL/PLYMR, NN-PRS, CALICUM-PHSPHT

Model Number	71332530
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed for the third time.Aseptic loosening.Hip prepped and draped, jointly opened, specimens taken.Joint lavaged and debrided intensely.The femoral head removed, poly liner and cup and screws removed.Existing socket reamed to a bleeding bone bed.Implant trailed, joint lavaged again with hydrogen peroxide and more saline.Definitive acetabular implant inserted with bone cement.Tripolar liner/head trailed via reduction, hip stable, definitive tripolar implants inserted and hip reduced, hip closed.No more information is available.
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 it was reported that a revision surgery was performed for the third time this year (2019) due to aseptic loosening.No supporting medical documentation was provided; therefore a thorough medical investigation could not be performed.Aseptic loosening was reportedly the cause.The patient impact beyond the loosening and revision procedure could not be determined.No further medical assessment could be rendered at this time.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 of this event could include a fit/ sizing issue, poor ingrowth or osteolysis.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 devices or additional information be received, the complaints will be reopened.No further investigation warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: REF SPHER HEAD SCREW 30MM
• Common Device Name: PROSTHSIS, HIP, SMI-CONSTRAIND, UNCMNTD, MTL/PLYMR, NN-PRS, CALICUM-PHSPHT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9353498
• Report Number: 1020279-2019-04110
• Device Sequence Number: 2219487
• Product Code: MEH
• UDI-Device Identifier: 03596010460479
• UDI-Public: 03596010460479
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K990666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 71332530
• Device Catalogue Number: 71332530
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1