MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BMHR HAP STEM VST SZ 4; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 74431314

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); External Prosthetic Device Pain (4560)

Event Date 07/26/2021

Event Type  Injury  

Event Description

It was reported that, after a bmhr modular head 52 mm and a bmhr stem were implanted during total hip replacement on (b)(6) 2010, the patient experienced intense pain and their hip was dislocated.This adverse event was treated by performing a revision surgery on (b)(6) 2021.Current health status of patient is unknown.

Manufacturer Narrative

H3, h6: it was reported that a hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the historical complaints data for the modular head was performed using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware date.No other similar complaints were identified to involve this batch and the part number and the reported failure mode.A review of the historical complaints data for the stem was performed using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware date.No other similar complaints were identified to involve this batch and the part number and the reported failure mode.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.All the 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.Bmhr have been phased out from the market and as a result there is no live risk management file to review.Therefore, an evaluation of failure modes is not required.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 and no further actions are required at this time.The available medical documents were reviewed.The provided x-ray was reviewed and supports the reported dislocation, as well the photo of the bmhr stem shows signs of damage.However, no conclusion can be made as to the clinical root cause of the dislocation but positioning of the acetabular cup cannot be ruled out.No other clinical/ medical documentation was provided.Without supporting medical documentation, a thorough medical assessment cannot be performed.In the event additional medical/clinical records are received, the clinical task may be re-opened and a thorough assessment will be rendered at that time.Without the return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.The investigation remains inconclusive, and a definitive root cause cannot be determined.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.If the products or additional information become available in the future, this case will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: BMHR HAP STEM VST SZ 4
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 12305548
• MDR Text Key: 265967627
• Report Number: 3005975929-2021-00371
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 03596010552617
• UDI-Public: 3596010552617
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2021

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 Expiration Date: 02/27/2014
• Device Catalogue Number: 74431314
• Device Lot Number: 08KW19518
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2021
• Initial Date FDA Received: 08/11/2021
• Supplement Dates Manufacturer Received: 12/21/2021
• Supplement Dates FDA Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/28/2009
• 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
• Patient Outcome(s): Hospitalization; Required Intervention