MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 36MM ID US CRMC LINER 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Catalog Number 71338952

Device Problems Insufficient Information (3190); Noise, Audible (3273)

Patient Problems Failure of Implant (1924); Discomfort (2330); No Code Available (3191)

Event Date 02/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that patient was presentend in office with a squeaking hip.The squeaking had become progressively worst and surgeon chose to revise to a poly liner and femoral head.

Manufacturer Narrative

A correction according to new informaton communicated to us on (b)(6) 2017.

• Brand Name: R3 36MM ID US CRMC LINER 52MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• 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: claudia de santis ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 6379763
• MDR Text Key: 69102129
• Report Number: 1020279-2017-00153
• 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: 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71338952
• Device Lot Number: 09MT38082
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2053-2058-2011
• Patient Sequence Number: 1
• Treatment: BIOLOX HEAD36MMS/+0 12/14TPR, (B)(4)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 89