MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR MODULAR HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74222146

Device Problems Unstable (1667); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Pain (1994); Discomfort (2330)

Event Date 01/24/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery from the right hip was performed due to pain, discomfort, and instability.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the hemi head and modular sleeve were removed.The bhr cup and 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.The cause of patient¿s reported pain and pseudotumor which led to the right hip revision cannot be determined, as the medical records for the period between the implantation operation and the revision were not provided.However, the patient¿s subsequent fluid aspirations and surgical cyst removals are likely a result of the reported tear in the joint fascia at the trochanter.It cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the revision, aspirations and fascia tear repair 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.Additional information: age , description of event or problem, device identification, medical products & therapy dates, initial reporter also sent reports to fda and device manufacture date.

Event Description

It was reported that a right hip revision surgery was performed due to pain, discomfort, inflammation, pseudo capsule was removed, and instability.

• Brand Name: BHR MODULAR HEAD 46MM
• 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: 8305361
• MDR Text Key: 135014345
• Report Number: 3005975929-2019-00051
• 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: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Catalogue Number: 74222146
• Device Lot Number: 10GW12456
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETLR CUP 74120152/ 10HW29693.; MODULAR SLEEVE 74222200/ 10CT40671.; SYN POR STEM 71306113/ 10HM17240.; SYNERGY FEM COMPONENT 71306113 UNK LOT.; UNKNOWN +0 MM MODULAR HEAD SLEEVE.; UNKNOWN 15 MM BHR ACETABULAR COMPONENT.; SYNERGY FEM COMPONENT 71306113 UNK LOT; UNKNOWN +0 MM MODULAR HEAD SLEEVE; UNKNOWN 15 MM BHR ACETABULAR COMPONENT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR