MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR RESURFACING FEMORAL HEAD 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74123152

Device Problems Mechanical Problem (1384); Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Injury (2348); Fibrosis (3167); Metal Related Pathology (4530)

Event Date 11/04/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed on the patient right hip due to elevated cobalt & chromium levels, metal-stained fibrotic tissue and pseudotumor-like tissue.The patient outcome is unknown.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.The devices involved were all used in treatment.As of today, additional information has been requested for this complaint but have not become available.Without definitive part and lot numbers a complaint history, dhr review and device labelling cannot be performed for the devices involved.Should the lot/batch/serial number become available at a later date then the complaint history task, dhr and device labelling will be re-opened and completed.A risk management review was performed.No additional risks were identified as result of the reported event.No further actions are required at this time.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.

Event Description

It was reported that, after undergoing right hip resurfacing (bhr), the patient suffered metallosis along with implant mechanical failure.The patient presented metal-stained fibrotic tissue and pseudotumor.These complications were treated by performing a revision surgery on (b)(6) 2019, in which both bhr components were explanted and replaced with a competitor¿s that system (zimmer-biomet).The patient left the operating room in stable condition.

Manufacturer Narrative

H10- additional information a1- patient identifier a2- age at the time of event a3- gender a4- patient weight b7- other relevant history, including preexisting medical conditions d4- expiration date d10- concomitant medical products g1- phone number g4- pma/510(k)number h4- device manufacture date h11- corrected data b1- adverse event and product problem.B3 - date of event b5- describe event or problem b6- relevant tests d1- brand name d4- catalog number, lot number, serial number ¿ please note that serial number is not appliable for this device, for which this space is intended to be left in blank.D6b- explanted date e1- initial reporter name g- contact office g2- report source h6- evaluation codes.

Manufacturer Narrative

It was reported that, after undergoing right hip resurfacing (bhr), the patient suffered metallosis along with implant mechanical failure.The patient presented metal-stained fibrotic tissue and pseudotumor.These complications were treated by performing a revision surgery in which both bhr components were explanted and replaced with a competitor¿s total hip arthroplasty system.The patient left the operating room in stable condition.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 head 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 bhr head, 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, 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 information provided the clinical root cause of the reported ¿metallosis¿ cannot be definitively concluded.It cannot be concluded the reported ¿metallosis¿ was associated with a mal performance of the implant or implant failure.The patient impact beyond the revision and post operative convalescence 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.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.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.

• Brand Name: BHR RESURFACING FEMORAL HEAD 52MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; spa park; austin, TX 78735 ; 5123913905
• MDR Report Key: 10418556
• MDR Text Key: 203284611
• Report Number: 3005975929-2020-00299
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552433
• UDI-Public: 03596010552433
• 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,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2015
• Device Catalogue Number: 74123152
• Device Lot Number: 10CW25879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/30/2010
• 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: ACTBLR CP SZ52/58(PN:74122158,LN:10FW28116)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 88 KG