MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121146

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Infiltration into Tissue (1931); Inflammation (1932); Pain (1994); Deformity/ Disfigurement (2360); Metal Related Pathology (4530)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case (b)(4).Article cite: samuel, l.T., zuke, w.A., mahmood, s., munim, m.A., alamir, p.B., & brooks, p.J.(2022).Hip resurfacing: a single surgeon u.S.Series with minimum ten-year follow-up.The journal of arthroplasty, s0883-5403(22)00399-0.Advance online publication.Https://doi.Org/10.1016/j.Arth.2022.04.008.

Event Description

It was reported that on literature review "hip resurfacing: a single surgeon u.S.Series with minimum ten-year follow-up¿ 7.4 years after a bhr surgery, one (1) patient had pain, high levels of metal ions (47.8 ppb of co and 47.5 ppb of cr), cup malposition with excessive anterversion and effusion.Revision surgery was performed to explant both implants.Competitor devices were implanted.The patient outcome and current health status is unknown.No further information is available.

Manufacturer Narrative

It was reported that on literature review "hip resurfacing: a single surgeon u.S.Series with minimum ten-year follow-up¿ 7.4 years after a bhr surgery, one patient had pain, high levels of metal ions (47.8 ppb of co and 47.5 ppb of cr), cup malposition with excessive anterversion and effusion.Revision surgery was performed to explant both implants and replace with competitor devices.The patient outcome and current health status is unknown.No further information is available and the devices, used in treatment, were not available for analysis.As no device part and batch numbers were provided for the bhr cup, a complaint history review, manufacturing record review, device labelling / ifu review could not be performed.A complaint history review was performed for the resurfacing femoral head 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.Similar complaints have been received, however this size of device is no longer sold, therefore no further action is required.A review of historic escalation actions related to the products and similar complaint events 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 are required.A risk management review was performed for the acetabular cup and femoral head.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.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be rendered nor can the root cause of the reported failure be determined.However, we cannot rule out the reported cup malposition with excessive anteversion as a likely contributory factor.The impact to the patient beyond that which has already been reported cannot be confirmed nor concluded.Therefore, no further medical assessment is warranted at this time.Should any additional relevant clinical information be provided, this complaint would be re-assessed.Without return of the actual devices or further information we cannot further investigate the details supplied in this complaint, our 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.No preventative or corrective action has been initiated as a result of this investigation.H11: updated/corrected information in h6 (health effect - clinical code and medical device problem code).

• Brand Name: RESURFACING FEMORAL HEAD 46MM
• 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: 14432362
• MDR Text Key: 292038237
• Report Number: 3005975929-2022-00268
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502780
• UDI-Public: 3596010502780
• 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: Study,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74121146
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Sex: Female