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

Catalog Number 74120262

Device Problems Migration or Expulsion of Device (1395); Device Slipped (1584); Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Toxicity (2333); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 11/04/2017

Event Type  Injury  

Event Description

It was reported that a revision surgery from the left hip was performed due to pain, loss of mobility, dislocation, loosening of the hip and metallosis.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the bhr dysplasia cup, dysplasia screws hemi head and modular sleeve were removed.The synergy stem remained 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.Elevated cobalt levels, migration, lucency around the cup from radiological studies, loosening, milky material from the hip joint and flocculent debris are consistent with findings associated with metallosis.However, without the radiology images and the return of the implant it cannot be confirmed.Both the loosening of the acetabular component and the loss of mobility were reported post the mva from 2007.Further, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond 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: 8295246
• MDR Text Key: 134690638
• Report Number: 3005975929-2019-00045
• 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
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2010
• Device Catalogue Number: 74120262
• Device Lot Number: 53633
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEMI HEAD 74122554, LOT 10044; SCREW 74500028 LOT 07HM09113; SCREW 74500032, LOT 07HM09929; SLEEVE 74222400, LOT 07JW14062; UNKNOWN BHR DEVICE/ UNKNOWN LOT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR