MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 36MM ID US CRMC LINER 52MM; PRSTHSS, HIP, SM-CNSTRND, METAL/CRMC/CRMC/METAL, CEMENTED OR UNCEMENTED

Catalog Number 71338952

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 05/21/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed to revise ceramic liner and biolox forte head due to a fall.The liner was broken and the head showed signs of wear.

Manufacturer Narrative

The associated complaint devices were not returned.A clinical evaluation was conducted and several attempts have been made to obtain clinical/medical documents.No documents were made available.It has been communicated that no information would be forth coming.Without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.A review of complaint history on the listed parts revealed no prior complaint for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.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 52MM
• Type of Device: PRSTHSS, HIP, SM-CNSTRND, METAL/CRMC/CRMC/METAL, CEMENTED OR UNCEMENTED
• 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: sarah freestone ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7590253
• MDR Text Key: 110699846
• Report Number: 1020279-2018-01098
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2018

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: 12/28/2019
• Device Catalogue Number: 71338952
• Device Lot Number: 09MT38082
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 05/21/2018
• Supplement Dates FDA Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2009
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR