MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122550

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Inflammation (1932); Necrosis (1971); Pain (1994); Synovitis (2094)

Event Date 08/27/2014

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to pain, metallosis, synovitis, inflammation, and tissue necrosis.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to pain, metallosis, synovitis, inflammation and tissue necrosis.During the revision the hemi head and modular sleeve were removed.As of today, device return and additional information has been requested for this complaint but has not become available.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.The available medical documents were reviewed.6 years post bhr implantation the patient was revised due to progressive pain and swelling of the right hip.The revision operative report was provided and reported signs of "metallosis and effusion with synovitis".The descriptions documented; metallosis, synovitis and large effusion are consistent with a metal on metal reaction.However, without metal ion levels, intra-operative pictures, the explanted components and pathology reports the source nor the root cause of the intraoperative findings can be confirmed.It was noted that use of a competitor's (stryker) dual mobility liner device was implanted with the bhr cup at the time of revision.This activity was performed contrary to the instructions for use of for bhr implants which states under its important medical information, "do not mix components from other manufacturers." without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: HEMI HEAD 50MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 6854762
• MDR Text Key: 85628285
• Report Number: 3005975929-2017-00271
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2018

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 Expiration Date: 05/31/2013
• Device Catalogue Number: 74122550
• Device Lot Number: 08EW17112
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/30/2017
• Initial Date FDA Received: 09/11/2017
• Supplement Dates Manufacturer Received: 08/30/2017; 08/30/2017
• Supplement Dates FDA Received: 11/09/2017; 09/27/2018
• Patient Sequence Number: 1
• Treatment: 71357108/ANTHOLOGY HO POR PLHASZ8/08BM18601A; 74120156/ACETLR CUP HAP 56MM W/IMPTR/089959; 74222200/MODULAR SLEEVE {} PLUS 0MM12/14/07LW14596; FEMORAL HEAD, PART AND LOT # UNKNOWN; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR