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

Catalog Number 74121146

Device Problems Compatibility Problem (2960); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Pain (1994); Arthralgia (2355); Inadequate Osseointegration (2646)

Event Date 07/01/2019

Event Type  Injury  

Event Description

It was reported that, after a bhr construct had been implanted in the left hip on (b)(6) 2011, the patient presented pain, fluid under pressure from effusion, and aseptic loosening.A revision surgery was performed on (b)(6) 2019 to treat the adverse event.The patient outcome is unknown.

Manufacturer Narrative

H3, h6: it was reported that left 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 complaint history for the bhr cup, bhr head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified for the head and cup.However, as the device is 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.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.Review of the product's instructions for use 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 available medical documents were reviewed.Without status post implantation and pre-revision x-rays, supporting lab/pathology results, and/or the analysis of the explanted components; the root cause of the femoral implant loosening cannot be confirmed and it cannot be concluded that the femoral loosening was associated with a mal-performance of the implant.The patient impact beyond the revision, and expected transient post-op convalescence period cannot be determined.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.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.

Manufacturer Narrative

H9: the concomitant product (74120152 / lot # 10cw26211) was also subject to a recall action under z-2746-2015.H3, h6.It was reported that left hip revision surgery was performed due to femoral aseptic loosening in conjunction with fluid under pressure from effusion in the hip joint and pain.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 bhr cup and head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified for both parts and this will continue to be monitored via routine trending, however it should be noted that devices of this size are no longer sold.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.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.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.The available medical documents were reviewed.With the limited information provided, the clinical root cause of the femoral implant loosening cannot be confirmed and it cannot be concluded that the femoral loosening was associated with a mal-performance of the implant.The patient impact beyond the revision, and expected transient post-op convalescence period cannot be determined.It is noted 3-months s/p left tha, ¿she is doing well.¿ without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.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.

Manufacturer Narrative

H10: additional information: a4: patient weight.B7: other relevant history.D10: concomitant medical products h11 ¿ corrected data.A1: patient identifier.B5: describe event or problem.E1: initial reporter name and address.G1: contact office.G1: phone number.H6: evaluation codes.

Event Description

It was reported that, after undergoing left hip resurfacing (bhr) on (b)(6) 2011 due to degenerative joint disease in conjunction with hip dysplasia, the patient suffered femoral aseptic loosening in conjunction with fluid under pressure from effusion in the hip joint and pain.These complications were treated by performing a revision surgery on (b)(6) 2019, in which the bhr head was explanted, and a smith and nephew tha system was placed instead.Patient's current health status is unknown.

• 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 ; UK
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, warwickshire ; UK
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; spa park; austin, TX 78735 ; 5123913905
• MDR Report Key: 10440218
• MDR Text Key: 204007069
• Report Number: 3005975929-2020-00313
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Catalogue Number: 74121146
• Device Lot Number: 10DW26927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2745-2015
• Patient Sequence Number: 1
• Treatment: ACTLR CUP52MM (PN:74120152,LN:10CW26211)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 84 KG