MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG HI LNR BIOLOX FORTE; HI-LUBRICER CERAMIC INSERT STD. 3-5/28

Model Number 0030933

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331)

Event Date 09/01/2014

Event Type  Injury  

Event Description

Revision surgery was reported due to pain.At revision surgery pronounced arthrofibrosis was detected.

Manufacturer Narrative

For investigation a hi-lubricer ceramic insert and a ceramic ball head from a third-party manufacturer were received.The damage of the face of the insert and the metal transfer markings visible on the articular surfaces were likely caused during revision.On the insert as well as on the ball head are matt areas visible which suggest repeated micro separation and edge loading of the insert.The metal transfer markings visible on the cone of the insert suggest an adequate connection between insert and acetabular shell.The received pre revision radiograph shows a limb length difference with a decrease in length of the operated side.During primary intervention implants¿ components from different manufacturers have been utilized.The combination of products supplied by the smith & nephew orthopaedics ag with products from third-party manufacturers is not allowed except with explicit direction from the product information, the surgical technique or the package insert stating that the combination of the implant systems is allowed.The information contained in the received surgical report of revision suggests that the pain experienced from the patient was likely due to psoas tendon impingement with the prosthetic components.

• Brand Name: HI LNR BIOLOX FORTE
• Type of Device: HI-LUBRICER CERAMIC INSERT STD. 3-5/28
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH50 00; SZ CH5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau 5000 ; SZ 5000
• Manufacturer Contact: tina mueller ; oberneuhofstrasse 10d; SZ 6340 ; 0628320660
• MDR Report Key: 4094755
• MDR Text Key: 4837144
• Report Number: 9613369-2014-00088
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/05/2014

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
• Device Model Number: 0030933
• Device Catalogue Number: 75001073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/05/2014
• Initial Date FDA Received: 09/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2007
• 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: THIRD PARTY CERAMIC BALL HEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 43 YR