MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL MM48; PRSTHSS,HIP,SEMI-CONSTRAINED,METAL/CRMC/CRMC/METAL,CMNTDORUNCMNTD

Catalog Number	71335548
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that in (b)(6) hospital, a surgeon performed a hip replacement surgery.The 48mm r3 acetabulum cup was in an appropriate location according to fluoroscopy.Then three screws were implanted, and implanted 48mm ceramic insert.After load test, a screw was found through the outer cup prosthesis screw hole directly into the pelvis.Subsequently the surgeon had a acetabulum side "revison" surgery, removed side prosthesis, found the screw hole deformation of acetabulum prosthesis.Then file to 54, outer cup trial implanted, it was stable.After that, 54 acetabulum prosthesis and ceramic insert were implanted.
Additional Manufacturer Narrative
The associated r3 shell and r3 ceramic liner were returned and evaluated.As reported, this issue is for a cancellous screw passing through a screw hole in the r3 shell but no screws were returned for analysis.The ceramic liner did not play a part in this issue.A lab analysis conducted during this investigation indicated that examination of the shell revealed some material embedded in the porous coating around the screw holes.This is possibly biological material transferred during momentary implantation.The shell was examined dimensionally and nothing was found to be out of specification with the exception of the screw hole which could not be measured with accuracy due to damage.Sem was used to more closely examine the screw hole damage.The damage pattern appears to be the result of a cutting action as opposed to a rolled deforming action from the spherical head of a screw.Eds was used to examine the damage surface for possible metal transfer from a cutting instrument such as a drill.The eds report did not find any elements other than the base material of the shell.Cancellous screws intentionally have very sharp thread crest to insure they gain purchase in bone.It appears the damage of the screw holes might possibly be due to the sharp screw thread cutting into the shell structure.No deviation was found from the standard manufacturing processes of the listed parts.Complaint history revealed no prior complaints for the listed failure mode with the same batch number.A clinical evaluation noted without the requested clinical information or radiographs the root cause of the reported issue cannot be determined.However, a user/procedural variance cannot be ruled out.No harm to the patient was reported as a result of this incident.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: R3 3 HOLE ACET SHELL MM48
• Common Device Name: PRSTHSS,HIP,SEMI-CONSTRAINED,METAL/CRMC/CRMC/METAL,CMNTDORUNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8107709
• Report Number: 1020279-2018-02610
• Device Sequence Number: 16673715
• Product Code: MRA
• UDI-Device Identifier: 03596010598226
• UDI-Public: 03596010598226
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P030022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2019

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: 71335548
• Device Lot Number: 17MM00179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 05/18/2019
• 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