MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

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

Patient Problems Failure of Implant (1924); Pain (1994); Skin Discoloration (2074)

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed in (b)(6) 2017 to remove bhr components due to significant pain with hip internal rotation and flexion.The patient was additionally found to have black tongue discoloration which had been present for 6 months.Patient presented metallic taste in the mouth.

Manufacturer Narrative

It was reported that hip revision surgery was performed.As of today, device return and additional information has been requested for this complaint but has not become available.As no device batch numbers were provided for investigation, a manufacturing record review could not be performed.If more information is received, this investigation will be reopened.The available medical documents were reviewed.In 2008, the patient was diagnosed with stage iv ovarian cancer.In march 2017, she had pain, black tongue discoloration, serum cobalt level of 39 ppb and chromium of 47.2 ppb.It was reported that intraoperatively there was a very large black fluid collection with extensive black-gray staining of the pericapsular tissues, muscle, and bone.There was significant fat necrosis with friable fat and capsule.It should be noted the patient had multiple rounds of chemotherapy, which may cause tongue hyperpigmentation or discoloration and cannot be ruled out as a contributing factor to the tongue discoloration.Other medications such as bismuth subsalicylate and some antibiotics are also known to cause black discoloration of the tongue the pain, elevated cobalt and chromium and black stained tissue, muscle, and bone are consistent with findings associated with pseudotumor and metallosis; however, without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the source of reactions cannot be confirmed, and it cannot be concluded that the reported events/clinical reactions were associated with a mal-performance of the implant.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: BHR ACETABULAR CUP
• 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: 9021225
• MDR Text Key: 159614483
• Report Number: 3005975929-2019-00329
• 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: health professional,study
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/05/2019
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR