MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BIRMINGHAM HIP MODULAR HEAD (BHMH) HEMI; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number UNKNOWN

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Infiltration into Tissue (1931)

Event Date 11/01/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that the plaintiff underwent a revision surgery on (b)(6) 2022 due to a left hip periprosthetic joint infection.The revision surgery consisted in: 1) the explantation of the bhr-tha system and placement of an articulating antibiotic spacer with acetabular and femoral components.2) irrigation and debridement procedure of the left hip skin, subcutaneous tissue, muscle, and bone.3) left hip proximal femur and extended trochanteric osteotomy.During the revision surgery, purulence was seen, as well as trunnion corrosion.The patient tolerated the procedure well.This patient had a previous left hip implant infection in (b)(6) 2021, which was treated with an irrigation and debridement procedure and iv antibiotic therapy.The primary left hip bhr tha procedure was performed on (b)(6) 2010.

Manufacturer Narrative

H3, h6: it was reported that a left hip revision surgery was performed due to infection.During the revision surgery, purulence was seen, as well as trunnion corrosion.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, device labelling / ifu, or definite escalation actions review could not be performed.If more information is received, this investigation will be reopened.A risk management review was performed for the hemi head and modular sleeve.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.A review of historic escalation actions for all hemi heads and sleeves and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions are required.The available medical documents were reviewed.The draining sinus and purulence is consistent with the reported recurring infection.However, the infections were highly likely of an exogenous nature and there is no evidence the infections were associated with the implant.The trunnion corrosion may be consistent with metal debris.However, the clinical root cause of the metal debris cannot be confirmed, and it cannot be concluded the clinical reactions were associated with a malperformance of the implant.Based on the available information we can confirm the reported complaint, however without further information our investigation remains inconclusive, and a definitive root cause cannot be determined.Specific factors known to contribute to the alleged faults are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement, loosening of components may increase production of wear particles and accelerate damage to the bone; the infections were highly likely of an exogenous nature.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: BIRMINGHAM HIP MODULAR HEAD (BHMH) HEMI
• 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15124672
• MDR Text Key: 296843641
• Report Number: 3005975929-2022-00440
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 07/28/2022
• Supplement Dates Manufacturer Received: 09/15/2022
• Supplement Dates FDA Received: 09/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN BIRMINGHAM HIP MODULAR HEAD (BHMH) SLEEVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male