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

Device Problems Inadequacy of Device Shape and/or Size (1583); Noise, Audible (3273); Patient Device Interaction Problem (4001)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Injury (2348)

Event Date 02/06/2017

Event Type  Injury  

Event Description

It was reported that a revision surgery from the right hip was performed due to allergic reaction to the metal-on- metal rubbing, metal debris, popping, pain, grinding and different leg lengths.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision the hemi head & modular sleeve were removed.The acetabular cup & stem remained implanted.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.Without definitive part/lot numbers a complete complaint history review cannot be performed for the devices involved.A review of the complaint history review was performed using the part number for a 74122550 hemi head 50mm, 74120150 acetabular cup 50mm & 74222300 modular sleeve +4mm.Similar complaints have been identified and this failure will continue to be monitored.Without the details of the devices involved in this complaint, the specific product labelling and ifus for the devices cannot be reviewed.A risk management review was performed.No additional risks were identified as result of the reported event.The medical documents were reviewed.It should be noted bhr is contraindicated in patients with known or suspected metal sensitivity.It cannot be determined to what extent the patient¿s fractured ilium and displaced fragment and advanced facet arthropathy had on her pain and clinical status.Cannot confirm leg-length discrepancy with the documentation provided.Pain, inflammation and adverse tissue reaction are findings associated with an allergic response.However, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.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: UNKNOWN BHR DEVICE
• 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: 8352610
• MDR Text Key: 136580792
• Report Number: 3005975929-2019-00076
• 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: other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• 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: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SMITH & NEPHEW ANTHOLOGY STEM; UNKNOWN BHR DEVICE/ UNKNOWN LOT
• Patient Outcome(s): Hospitalization; Required Intervention