MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BMHR HAP STEM VST SZ 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74431313

Device Problems Material Erosion (1214); Naturally Worn (2988)

Patient Problems Osteolysis (2377); Insufficient Information (4580)

Event Date 01/08/2024

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: case (b)(4).Bilateral hip captured under case (b)(4).

Event Description

It was reported that, after a bmhr system had been implanted bilaterally in a patient on 2011, the patient experienced neck thinning.The right knee has already been revised; the implants show some metal wear of the head/stem junction.The left knee will be revised in the future.It cannot be determined, based on the implant chart sticks, which implants are associated to each hip.Health status of the patient is unknown.

Manufacturer Narrative

H3, h6: it was reported that an implanted birmingham mid head resection has shown neck thinning and some metal wear of the head/stem junction.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.A review of the historical complaints data for the alleged devices was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.No other similar complaints have been identified for the cup, the head and the stem, this failure will continue to be monitored for the cup and will continue to be monitored via routine trending for the head and the stem, however it should be noted that these last two devices are no longer sold.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.The review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.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 related to the products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.The available medical documents were reviewed.The reported neck thinning is possibly stress shielding over time changing the needed bone support of the femoral neck but osteolytic changes as an inflammatory response cannot be ruled out.With the limited information provided the clinical root cause cannot be confirmed.The patient impact is the right revision.A pending left revision was reported, no imaging or clinical documentation regarding the left hip was provided.Based on the information provided, further investigation of the reported complaint cannot be carried out and remains inconclusive.A definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement.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.H11- corrected data b1- adverse event and product problem.B2- outcomes attributed to adverse event.

• Brand Name: BMHR HAP STEM VST SZ 3
• 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: 18641814
• MDR Text Key: 334564027
• Report Number: 3005975929-2024-00009
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010617620
• UDI-Public: 3596010617620
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2013
• Device Catalogue Number: 74431313
• Device Lot Number: 08KW19542R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2008
• 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: PN: 74122154, LOT: 10KW30550; PN: 74432048, LOT: 08KW19338
• Patient Outcome(s): Other; Required Intervention