MAUDE Adverse Event Report: SMITH&NEPHEW, INC PLUS; CERAMIC BALL FEM HEAD

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 01/08/2014

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to implant breakage.

Manufacturer Narrative

Upon receipt of additional information, it was determined the device involved in the revision surgery was not a product of smith&nephew, inc.As a result, this medwatch was filed in error.Based on the information provided, a smith&nephew device did not cause or contribute to a death or serious injury, nor has it been implicated by the physician.In addition, the information provided does not reasonably suggest that a smith&nephew device malfunctioned.Therefore, under the regulations set forth under 21 cfr 803, it is concluded that this is not a reportable event.

• Brand Name: PLUS
• Type of Device: CERAMIC BALL FEM HEAD
• Manufacturer (Section D): SMITH&NEPHEW, INC; schachenallee 29; aarau CH50 00; SZ CH5000
• Manufacturer (Section G): SMITH&NEPHEW, INC; schachenallee 29; aarau CH50 00; SZ CH5000
• Manufacturer Contact: phillip emmert ; 1450 e. brooks rd; memphis, TN 38116 ; 9013995296
• MDR Report Key: 3574436
• MDR Text Key: 4075594
• Report Number: 9613369-2014-00001
• Device Sequence Number: 1
• Product Code: LPF
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/29/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/08/2014
• Initial Date FDA Received: 01/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/29/2014
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 105