MAUDE Adverse Event Report: SMITH & NEPHEW, INC.; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Device Problem Metal Shedding Debris (1804)

Patient Problem Injury (2348)

Event Date 01/23/2017

Event Type  Injury  

Event Description

It was reported that patient had a revision surgery due to an adverse reaction to metal debris.

Manufacturer Narrative

The associated complaint device was not returned for evaluation the associated complaint device was not returned for evaluation.Our clinical/medical investigation concluded: based on the lack of information, the ¿adverse reaction to metal debris¿ is not supported and cannot be concluded at this time.Should any relevant clinical/medical information become available the complaint can be re-assessed.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.

• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• 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 rd; memphis, TN 38116
• MDR Report Key: 7322854
• MDR Text Key: 101830943
• Report Number: 1020279-2018-00277
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• 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
• Date Manufacturer Received: 02/11/2018
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR