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

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

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

Event Date 01/09/2017

Event Type  Injury  

Manufacturer Narrative

It was reported that the surgeon doesn't fault the product and that the implants won't be returned.Acetabular cup information are unknown as the explant was destroyed and no initial surgery data is available.

Event Description

It was reported that revision surgery occured on patient right hip due to implant migration when cemented acetabular cup migrated medially into the pelvis.Cpcs stem and cemented cup removed.

• Brand Name: CEMENTED ACETABULAR CUP - UNKNOWN
• 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: claudia de santis ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 6253031
• MDR Text Key: 64924095
• Report Number: 1020279-2017-00032
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2017
• 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?: Yes
• Date Manufacturer Received: 01/09/2017
• 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: COCR12/14FEMHD32+0, PART#71303200,LOT#16DM18737; CPCS COCR SO12/14SZ1,PART#71312361,LOT#16CM21545
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR