MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR RESURFACING FEMORAL HEAD 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74123156
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Arthralgia (2355)
Date of Event	03/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: case-(b)(4).H10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.
Event or Problem Description
It was reported that the plaintiff underwent a primary bhr resurfacing left hip surgery on (b)(6) 2013 and subsequently suffered from left hip pain.This adverse event was addressed by revision surgery on (b)(6) 2018 to explant the bhr resurfacing femoral head 56mm and acetabular cup hap size 56/62.A competitor¿s 64 mm allofit shell, 36 mm inner diameter highly cross-linked polyethylene elevated rim liner, taperloc stem high offset 20 x 125 and a 36 biolox delta modular head 36 +3 mm were used instead to complete revision surgery.The patient was transferred to the recovery room without issue.
Additional Manufacturer Narrative
Section h3, h6: it was reported that the patient underwent a primary bhr resurfacing left hip surgery and subsequently suffered from left hip pain.This adverse event was addressed by revision surgery to explant the bhr resurfacing femoral head 56mm and acetabular cup hap size 56/62.A competitor¿s system was used instead to complete revision surgery.The patient was transferred to the recovery room without issue.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.Similar complaints have been identified for the head and no other similar complaints have been identified for the cup, and this failure will continue to be monitored.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.With the limited information provided the clinical root cause of the reported pain cannot be confirmed.It cannot be concluded the reported pain was associated with the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.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.Based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.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.H6: health effect - clinical code.

• Brand Name: BHR RESURFACING FEMORAL HEAD 56MM
• 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: 17685703
• Report Number: 3005975929-2023-00137
• Device Sequence Number: 6179761
• Product Code: NXT
• UDI-Device Identifier: 03596010552440
• UDI-Public: 03596010552440
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2023

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: Lay User/Patient
• Device Expiration Date: 09/29/2015
• Device Catalogue Number: 74123156
• Device Lot Number: 10JW14737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2010
• 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: 74122162/ACETABULAR CUP HAP SIZE 56/62
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male