MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 CONST 58MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number	71339158
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/06/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to dislocation of r3 constrained liner.
Event or Problem Description
It was reported that a revision surgery was performed to change the liner due to dislocation.
Additional Manufacturer Narrative
The associated complaint devices were returned.It was reported that after several years insitu, an r3 liner and oxinium femoral head were revised to an r3 constrained liner due to recent dislocation and disassociation from the acetabular cup.There have been three unsuccessful attempts to obtain supporting medical documentation, and very limited complaint details have been provided.The patient impact beyond the revision surgery cannot be determined as there is no report of the patient¿s current condition or how the procedure was tolerated.No further clinical assessment can be performed.The visually identified scratches and gouges on the femoral head are consistent with damage likely caused by articulating contact with another metal component such as the shell.Scratches on the face and chamfer areas leading into the internal taper were likely produced during removal/extraction of the head.The constrained liner is an assembly of 7 components, and two were not returned.Deformed edges on the inner and outer poly liner components were observed along with a darker stained edge on the cocr inner shell.It was noted all of these observed features appeared to fall along a linear line extending outward from the perceived center.These features were likely formed due to an impingement with another component.A review of complaint history revealed no prior complaints for the listed batch of femoral head.A review of the manufacturing records did not reveal any deviations that could have caused or contributed to the reported incident.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: R3 CONST 58MM
• 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: 7140014
• Report Number: 1020279-2017-01323
• Device Sequence Number: 69094
• Product Code: KWZ
• UDI-Device Identifier: 00885556020876
• UDI-Public: 00885556020876
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/10/2018

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: 71339158
• Device Lot Number: 09JM07728
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 12/06/2017; 12/06/2017
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 03/28/2018; 05/10/2018
• 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