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

Catalog Number 74222148

Device Problem Biocompatibility (2886)

Patient Problems Infiltration into Tissue (1931); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 11/13/2018

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

(b)(6) bilateral patient.It was reported that, after a primary bhr-tha construct had been implanted on the plaintiff¿s left hip on (b)(6) 2009, the plaintiff experienced elevated metal ion levels in blood.A revision surgery was performed on (b)(6) 2019 to treat this adverse event.The bhr modular head 48mm was explanted.During revision surgery, some osteolysis was noticeable around the acetabular cup area, which was scraped and replaced with a substitute material made of calcium phosphate.The procedure was concluded with no complications.

Manufacturer Narrative

G3, h2, h3, and h6: it was reported that a left hip revision surgery was performed due to elevated metal ion levels in blood.The modular head and sleeve used in treatment were both explanted but were not returned for evaluation.The other devices used in treatment remain implanted in the patient, hence cannot be returned for evaluation.Additional information has been requested for this complaint but has not become available.A review of the complaint history for the modular head, cup, and sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the cup or head.Similar complaints have been identified for the sleeve.However, as the device is no longer sold, no action is to be taken.On account of the fact devices reportedly involved in this incident were not returned for evaluation, the relevant production records were reviewed.All released devices involved met manufacturing specifications upon release for distribution.Review of manufacturing records did not reveal any waivers, concessions, manufacturing, or material abnormalities that could have contributed to this issue.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.No further actions are required at this time.The available medical documents were reviewed.The reported elevated metal ion levels, intraoperative findings of soft tissue reaction, osteolysis, inflammatory tissue, and cavities may be consistent with findings associated with metal debris.However, the source of the reactions cannot be confirmed, and it cannot be concluded that the reported events/clinical reactions were associated with a mal performance of the implant.The patient impact beyond the revision and expected transient post-op convalescence period cannot be determined.Without the return of the actual product involved or further product information, our investigation could not proceed and remains inconclusive, and a definitive root cause cannot be determined.Furthermore, based on the limited information provided, we are unable to determine specific factors known to contribute to the alleged fault.Should the device or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.No further investigation is warranted for this complaint.D10: add concomitants h6: update codes.

• Brand Name: BHR MODULAR 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 warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 12526194
• MDR Text Key: 273121889
• Report Number: 3005975929-2021-00427
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552471
• UDI-Public: 3596010552471
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2013
• Device Catalogue Number: 74222148
• Device Lot Number: 08GW17791
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANTHOLOGY SO POROUS SIZE 6/07GM09020; MODULAR SLEEVE -4MM 12/14/07LW14551
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 68 YR