MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG BIPOLAR PROSTHESIS 48/28; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number 16766

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 12/20/2016

Event Type  Injury  

Event Description

Revision surgery was performed due to pain and migration.

Event Description

Revision surgery was performed due to pain and migration of the bipolar head.

• Brand Name: BIPOLAR PROSTHESIS 48/28
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 6340 ; SZ 6340
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau 5001 ; SZ 5001
• Manufacturer Contact: claudia de santis ; 0628320660
• MDR Report Key: 6236066
• MDR Text Key: 64249754
• Report Number: 9613369-2017-00001
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K982447
• 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,Followup
• Report Date: 12/27/2016

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 Model Number: 16766
• Device Catalogue Number: 75004344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/27/2016
• Initial Date FDA Received: 01/10/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/10/2017; 03/13/2017
• 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
• Patient Sequence Number: 1
• Treatment: BIPOLAR PROSTHESIS 48/28, PART 75004344, LOT NI
• Patient Outcome(s): Hospitalization; Required Intervention