MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG METAL BALL HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Device Problem Insufficient Information (3190)

Patient Problem Ossification (1428)

Event Date 05/19/2016

Event Type  Injury  

Manufacturer Narrative

Event Description

Right hip, ossification at 10-year study follow-up, brooker classification grade iv.Ossification was detected by the study center the first time at the 3-months follow-up in 2006.

• Brand Name: METAL BALL HEAD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, 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 odoy ; 0628320660
• MDR Report Key: 5754489
• MDR Text Key: 48301523
• Report Number: 9613369-2016-00038
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K001942
• 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: 05/30/2016

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2016
• Initial Date FDA Received: 06/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/12/2016
• 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: FITMORE PE-INSERT X-LINKED STANDARD (3RD PARTY P.)
• Patient Outcome(s): Disability
• Patient Age: 64 YR
• Patient Weight: 92