MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 36MM ID US CRMC LINER 54; PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC,CEMENT/UNCEMENT

Catalog Number 71338954

Device Problem Fracture (1260)

Patient Problems Injury (2348); Limited Mobility Of The Implanted Joint (2671)

Event Date 12/07/2017

Event Type  Injury  

Event Description

It was reported that a revision surgery was required to replace a fractured cup.

Event Description

It was reported that the "patient complained of instability, upon revision noticed liner was cracked." only the liner and head were revised during the procedure.

Manufacturer Narrative

The associated complaint devices were not returned for evaluation.A clinical evaluation noted there are no supporting clinical documents provided for review and inclusion in an investigation.Therefore, due to insufficient information, a clinical assessment is not able to be performed.Our investigation included a review of the manufacturing records which did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.Without the return of the actual product involved, our investigation of this report is inconclusive.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: R3 36MM ID US CRMC LINER 54
• Type of Device: PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC,CEMENT/UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: markus poettker ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7147580
• MDR Text Key: 95811107
• Report Number: 1020279-2017-01344
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030022/S008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2018
• Device Catalogue Number: 71338954
• Device Lot Number: 08GT22381
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 12/27/2017
• Supplement Dates Manufacturer Received: 12/07/2017; 12/07/2017
• Supplement Dates FDA Received: 02/21/2018; 04/11/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN HEAD; UNKNOWN LINER
• Patient Outcome(s): Hospitalization; Required Intervention