MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 CONST 54MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number	71339154
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision was performed due to metal ring holding r-3 constrained liner broke when patient fell, causing constrained liner to come apart.No delay or back up reported.
Additional Manufacturer Narrative
The associated complaint devices were returned for evaluation.The visual inspection of the constrained liner revealed damage to the front rim.The damage is most likely the result of impingement with the neck of the femoral component over some period of time.The backside of the liner does exhibit yellow staining.Yellow staining is usually the result of biological fluid being absorbed overtime.The inner shell found only slight marks most likely the result of the removal process.The outer support ring was found to be broken.The break in the ring would have allowed the constrained liner to disassemble.The fracture exhibits a fatigue crack initiating in the outer surface of the ring.A fatigue crack may have formed as a result of cyclic load being applied by the neck impingement in the liner noted earlier.The final fracture revealed from the surfaces occurred when the ring was subjected to an excessive force most likely from the patient falling.The returned oxinium head exhibited some scoring/scratching on the articular surface and lower rim.These were caused by contact with another metal object.Possibly with metal components in the total assembly or an instrument, during removal.It cannot be determined when this actually occurred.It does not appear the head contributed to the fracture of the metal ring.There is no indication of a deviation of material or process during the components manufacturing.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Our clinical/medical team noted no relevant clinical medical information was provided to conduct a thorough medical assessment.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: R3 CONST 54MM
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8078883
• Report Number: 1020279-2018-02524
• Device Sequence Number: 1691796
• Product Code: KWZ
• UDI-Device Identifier: 00885556020227
• UDI-Public: 00885556020227
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2019

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 Catalogue Number: 71339154
• Device Lot Number: 17GM15786
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 03/19/2019
• 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: 71342200/17JM12274UNKNOWN HIP IMPLANT X3
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention