MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 42MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121142

Device Problems Biocompatibility (2886); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Osteolysis (2377)

Event Date 03/08/2022

Event Type  Injury  

Event Description

It was reported that, after undergoing right hip resurfacing (bhr) on (b)(6) 2008 due to hip dysplasia with osteoarthritis and chronic hip pain, the patient experienced pain and elevated metal ions in blood.In addition, an mri revealed an edema in the subtrochanteric region.These symptoms were addressed by performing a revision surgery on (b)(6) 2022, in which both resurfacing components were explanted and a competitor¿s tha construct (zimmer-biomet-j&j depuy) was placed in exchange.During this procedure, the bhr femoral head was noticed to be loose.Surgery was successfully completed, and the patient was transferred in stable condition to the post-anesthesia care unit.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Internal reference number: (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.

Manufacturer Narrative

H9: fda recall reference - z-2267-2018 & z-2268-2018 and fda recall reference - z-2746-2015 and z-2745-2015.Section h3, h6:it was reported that, after undergoing a right hip resurfacing surgery due to hip dysplasia with osteoarthritis and chronic hip pain, the patient experienced pain and elevated metal ions in blood.As of today, the devices, which were used in treatment, have not been returned for evaluation.A review of the complaint history for the head and cup was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified to involve for either batch.Other similar complaints have been identified for the part number and the reported failure mode in this timeframe, 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 the released devices involved met manufacturing specifications at the time of production.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.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.A review of historic quality escalations 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 required.It was also confirmed that the devices were produced before corrective actions were implemented the available medical documents were reviewed.The reported ratcheting, pain, loosened femoral component and elevated cobalt and chromium may be consistent with the osteolytic changes around the femoral neck.It cannot be concluded the osteolytic changes were associated with a mal performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.No further clinical assessment is warranted at this time.Based on the information provided we cannot further investigate the complaint our investigation remains inconclusive and 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, loosening of components may increase production of wear particles and accelerate damage to the bone.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 action is not indicated.H6: health effect - clinical code and health effect - impact code.

• Brand Name: RESURFACING FEMORAL HEAD 42MM
• 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: 17092218
• MDR Text Key: 316855687
• Report Number: 3005975929-2023-00096
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502773
• UDI-Public: 3596010502773
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/03/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2013
• Device Catalogue Number: 74121142
• Device Lot Number: 085972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/17/2023
• Initial Date FDA Received: 06/08/2023
• Supplement Dates Manufacturer Received: 06/29/2023
• Supplement Dates FDA Received: 07/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2008
• 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: 74120148/ACETLR CUP HAP 48MM W/ IMPTR
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Female