MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122550

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

Patient Problems Metal Related Pathology (4530); Unequal Limb Length (4534)

Event Date 04/16/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient underwent revision surgery due to a failed right hip tha with metal related pathologies (alval).

Manufacturer Narrative

It was reported that a right 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, hemi head and modular sleeve and stem was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the bhr cup and stem.Similar complaints have been identified for the hemi head and sleeve.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 known 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 and no further actions are required at this time.Smith and nephew has not received the explanted device or adequate materials to fully evaluate the complaint.If additional clinically relevant materials are later received and/or the product evaluation offers information that is clinically relevant to the medical investigation, then the case may be re-opened for further evaluation.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 a right bhr-tha construct had been implanted on (b)(6) 2011, the patient sustained hip pain and massive metal reaction with extensive necrosis of pericapsular tissues in the right hip (alval).A revision surgery was performed on (b)(6)2019 to treat these complications.During this procedure, the modular head and sleeve were explanted and replaced with a dual mobility xlpe liner and an oxinium femoral head.Intraoperatively, black corrosion was noted on the stem trunnion and on the inside trunnion of the femoral head.The necrotic tissue around the hip was excised.The patient tolerated well the procedure.

Manufacturer Narrative

Additional information: a2, a4, b6, b7, d4 (expiration date), d10, e4, h4.Corrected data: b3, b5, h6 (health effect - clinical code, medical device problem code).

Manufacturer Narrative

Section h3, h6: it was reported that a right hip revision surgery was performed due to pain and metal reaction with extensive necrosis of pericapsular tissues in the hip (alval).As of today, the implanted devices, used in treatment, have been requested for this complaint but have not become available.A review of the complaint history for the hemi head, modular sleeve and femoral stem was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Other complaints were identified to involve the hemi head batch.Other similar complaints were identified for the part number and the reported/related failure mode for the head and sleeve.This will continue to be monitored, although these parts are no longer sold.In the absence of the actual devices, the production records were reviewed for the known 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 and no further actions are required at this time.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 reported pain, elevated cobalt, and intraoperative findings; beige toothpaste appearing fluid, extensive necrosis, and black corrosion products on the trunnion and on the inside trunnion of the femoral head may be consistent with the reported metallosis.However, with the information provided the clinical root cause of the reported clinical reactions cannot be confirmed.It cannot be concluded the reported clinical reactions were associated with a mal-performance of the implant or implant failure.The patient impact beyond the revision cannot be determined; however, a clinic note 12 weeks post revision noted, ¿he is recovering appropriately from a right hip revision.¿ based on the available information 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.Should the device 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: HEMI HEAD 50MM
• 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: 11355467
• MDR Text Key: 232792460
• Report Number: 3005975929-2021-00094
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 00885556071205
• UDI-Public: 885556071205
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2014
• Device Catalogue Number: 74122550
• Device Lot Number: 09BW04015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2009
• 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: PN: 71356108 / LOT: 10EM08814; PN: 74222300 / LOT: 08LW19887
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 87 KG