MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD FEMORAL HEAD 44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74123144
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530); Unequal Limb Length (4534)
Date of Event	05/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
**us legal mdl** it was reported that after a left bhr construct was implanted on (b)(6)2012 plaintiff experienced leg discrepancy over 2cm, progressive pain, and difficult ambulation.A revision surgery was performed on (b)(6) 2021 to treat these adverse events.During the surgery a large hemarthrosis was found and evacuated.Also, pseudotumor tissue found an extensive synovitis around the femoral neck.The liner and bhr head were explanted and replace, but the acetabular cup remained.Additionally, a stem (not from s+n) was implanted.Patient outcome is unknown.
Additional Manufacturer Narrative
H3, h6: it was reported that a left hip revision surgery was performed.During the revision, the r3 liner and bhr femoral head were explanted.The acetabular cup remained implanted.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 complaint history for the r3 liner and the femoral head 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 r3 liner.Other similar complaints were identified for the femoral head.However, as the device of this size is no longer sold, no action is to be taken.A review of the historical complaint data for the r3 liner and the femoral head was performed using related reported failures and the part number for the prior 12 months as of the complaint aware date.Other similar complaints were identified for the r3 liner and the femoral head.However, as the devices are no longer sold, no action is to be taken.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.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.Bhr resurfacing systems =46mm/ r3 liners 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.The available medical documents were reviewed.The leg length discrepancy is related to the primary surgery and not the implant device as the surgeon indicated the patient¿s leg lengths were fairly similar to preoperative lengths with significant shortening of the left lower extremity.Per the surgical technique, the acetabular component is to be impacted with 15-20 degrees of anteversion and 40-45 degrees inclination angle.However, the implantation operative report indicated the acetabular component was placed at 10-15 degrees of anteversion.It is unknown if the position of the acetabular cup accelerated wear and lead to metal debris and resulted in the reported pain, difficulty ambulating and intraoperative findings of grossly loose and mobile femoral component, pseudotumor, and synovitis.The grossly loose and mobile femoral component can also accelerate wear and lead to metal debris and result in the reported clinical reactions and intraoperative findings.However, without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the report clinical reactions cannot be confirmed.It cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant or implant failure.The patient impact beyond revision and expected transient post-op convalescence period cannot be determined.Without the return of the actual devices or further information we cannot further investigate or confirm the reported complaint, or the details supplied in this complaint.The investigation remains inconclusive, and a definitive root cause cannot be determined.Based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.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: FEMORAL HEAD 44MM
• Common Device Name: 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: 12639264
• Report Number: 3005975929-2021-00474
• Device Sequence Number: 1402713
• Product Code: NXT
• UDI-Device Identifier: 03596010552419
• UDI-Public: 3596010552419
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/30/2013
• Device Catalogue Number: 74123144
• Device Lot Number: 08MW20907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/31/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71335556-R3 3 HOLE ACET SHELL 56MM; 71335556-R3 3 HOLE ACET SHELL 56MM
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 59 YR
• Patient Sex: Female