MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD FEMORAL HEAD 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74123148

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Test Result (2695)

Event Date 01/27/2016

Event Type  Injury  

Event Description

It was reported that patient underwent left hip revision surgery due to metallosis, elevated cobalt and chromium levels, and pseudotumor.

Manufacturer Narrative

It was reported that left hip revision surgery was performed due to elevated cobalt and chromium levels and pseudotumor.During the revision the bhr head was removed.The bhr cup remains implanted.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.This 53 year old male underwent a left bhr revision ~ 3 years post implantation due to reported metallosis, elevated metal ion levels, pseudotumor.The revision operative report indicated that patient's blood test for cobalt and chrome levels were very high, in addition to developing metallosis.Additionally, the op-report stated that the plan was to use the retained smith and nephew bhr cup, which was well fixed and appropriately positioned, with a stryker adm dual-mobility bearing neck.Pt.Understood that this was a non-fda approved indication for use.Intraoperatively, a small amount of blood-tinged synovial fluid was obtained and sent for synovial fluid white blood cell count.Neither supporting intra-op findings/images nor pathology/lab results were provided to confirm the reported metallosis.The clinical symptoms of the reported metallosis, elevated cobalt/chrome levels and pseudotumors may be consistent with an adverse reaction to metal debris, but this cannot be confirmed based on the information provided.The source of the reported elevated metal ions cannot be determined.It was noted that use of a competitor's (stryker) dual mobility liner, femoral stem and (biolox) femoral head devices were 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: FEMORAL HEAD 48MM
• 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau 05001 ; SZ 05001
• MDR Report Key: 7095147
• MDR Text Key: 94094681
• Report Number: 3005975929-2017-00446
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: 74123148
• Device Catalogue Number: 74123148
• Device Lot Number: 12CW36734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/29/2012
• 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: FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR