MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 CONST 56MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Model Number	71339156
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision thr of a periprosthetic fracture was performed around an exeter stem and unitrax bipolar head.The patient had a 44mm +0 exeter stem and a 55mm bipolar head.This was removed along with the cement and the femoral fracture was reduced and cabled.The intention was to use an r3 56mm constrained liner and 22mm head.The acetabulum was reamed 70 55mm and a 56mm 3 hole r# cup was implanted with one screw.A trial 36mm liner was inserted.The femur was prepared for an echelon 265 x 16mm bowed stem.Trialing was done using a couple of 36mm head lengths.The trial liner was removed and the r3 56mm constrained liner was implanted.The 22mm +0 ox head was implanted and the hip reduced.Reduction was difficult as the hip was a little tight.When the head was reduced into the liner there was no audible click of the head locking in.During rom testing it was found that with the hip at 90deg of flexion and 10deg of internal rotation the head would dislocate from the liner.Reduction was tried a number of times.The surgeon then impacted the stem further to make the joint less tight.Reduction was done again but the problem of dislocation in the same position persisted.The inner part of the liner was checked and confirmed it was perpendicular the neck.When the hip was manipulated the inner part of the liner moved to the same position each time allowing the head to dislocate at the same position.Eventually it was decided to remove the liner by cutting it out, remove the head and exchange the 2 implants for a 36mm +4 lateralized liner and a 36mm head.This was stable and the surgery continued.
Additional Manufacturer Narrative
The associated devices, used in treatment, were returned and evaluated.The lab analysis included only visual observations.The femoral head exhibited an area of scoring on the articulating surface.For this to occur the head had to encounter a metal object.It is possible the head made metal contact during the reduction.The report notes the liner component had to be cut out in order to remove it.Visually this is confirmed.This indicates the liner was securely locked in place.Further examination revealed another cut across the polyethylene rim of the inner component.It is not clear why this had to be cut.From the provided information, conclusions as to why this issue occurred cannot be made.The medical investigation concluded that, per the lab retrieval analysis, ¿conclusions as to why this issue occurred cannot be made¿.It is unknown if the reported ¿tight hip¿, lack of an audible head reduction or implant positioning could have contributed to the reported repeated dislocations and revision to alternative components as reportedly the lateralized +4mm liner with a 36mm head ¿was stable and the surgery continued.¿ the patient impact beyond the reported events could not be determined.No further medical assessment can 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 do not have 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 poor device positioning or selection.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: R3 CONST 56MM
• 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: 9384407
• Report Number: 1020279-2019-04179
• Device Sequence Number: 14005175
• Product Code: KWZ
• UDI-Device Identifier: 00885556020470
• UDI-Public: 00885556020470
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2020

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: 08/31/2024
• Device Model Number: 71339156
• Device Catalogue Number: 71339156
• Device Lot Number: 14JM01380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 06/13/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 06/17/2020
• 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: Required Intervention