MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 44/52; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74122152

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

Patient Problems Pain (1994); Arthralgia (2355); Metal Related Pathology (4530); Insufficient Information (4580)

Event Date 09/07/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case (b)(4).

Event Description

It was reported that, after a bhr surgery had been performed on an unspecified date, the patient presented an unspecified condition that required a revision surgery on (b)(6)2021.Patient outcome is unknown.

Manufacturer Narrative

It was reported that a left hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.Since part/lot details were not received for investigation no thorough manufacturing record review or assessment of the reported event can be performed.If the products or additional information become available in the future, the tasks will be reopened and performed.However, the released devices would have met manufacturing specifications at the time of production.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.The available medical documents were reviewed.This case reports the patient had pain in the left hip and a revision tha surgery was performed.It was communicated via e-mail that a large amount of metallosis was found during the revision surgery.It was also noted that no additional medical documentation is available.Smith and nephew has not received the explanted device and/or adequate materials to fully evaluate the complaint.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Without the return of the actual products involved or additional information, we cannot advance the investigation or confirm 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.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.

Manufacturer Narrative

Sections b4, d4, h4 and h6 were updated due to new information received.

Event Description

It was reported that, after a thr surgery had been performed on an unspecified date, the patient presented pain on the left hip, which caused a revision surgery on (b)(6) 2021.On opening of the capsule a large amount of metallosis was found due to the wear from the taper/stem.Cup and stem were removed and a full tha revision was performed as well as a debridement of the surrounding tissue.The patient's outcome is unknown.

Manufacturer Narrative

Additional information: a2, a3, d5, d6b, d7a, g4 (510k).Results of investigation: a bhr modular head and sleeve (part and lot obscured), bhr cup (b)(6) and synergy stem (part and lot obscured) were received for investigation following left hip revision surgery.The devices were used in treatment.A review of the historical complaints data for the acetabular cup was performed using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and using part numbers 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.Other complaints were identified to involve this batch.Other similar complaints were identified for the part number and the reported/related failure mode.However, as the device is no longer sold, no action is to be taken.As no part or batch numbers were identified for the head, sleeve and stem a complaint history review for these devices could not be performed.The production records were reviewed for the devices involved in this incident for which device details were available.All released devices involved met manufacturing specifications upon release for distribution.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.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.Visual inspection was carried out on the returned devices.Scratches were observed on the bearing surface of the bhr cup and modular head.Damage was observed to the taper and neck of the stem.Damage was also observed to the base of the head taper.Surface texture change and discolouration were observed on the internal sleeve taper.The sleeve could not be removed from the head without using excessive force wear analysis was performed to review linear wear on the bearing surface of the modular head and bhr cup.The wear images identified a wear patch on the bearing surface for the bhr head, and a wear patch on the bhr cup.The position of wear on the acetabular cup shows that the femoral head was articulating within the bearing surface of the cup.Maximum linear wear for the bhr head was 19.8¿m.On the bhr cup maximum linear wear was 23.2¿m for a combined head & cup maximum wear of 43.0¿m.Measurement of the vertical straightness profile of the internal sleeve taper showed material loss to a maximum depth of 318.0 ¿m.Time in vivo is needed to compare the measured combined linear wear for this device with the historical wear data for a non-edge loaded smith and nephew large diameter metal-on-metal device.The position of wear on the acetabular cup shows that the femoral head was articulating within the bearing surface of the cup.Material loss was measured on the internal taper of the sleeve.A medical investigation was performed.The product evaluation was reviewed and the noted, material loss on the internal taper of the sleeve, surface texture change and discoloration on the internal sleeve taper which may be consistent with the reported ¿large amount of metallosis due to the wear from the taper/stem.¿ however, as of the date of this medical investigation, the requested supporting clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the wear on the taper/stem.The patient impact beyond the reported clinical reactions and revision cannot be determined.Based on the information provided, the reported wear on the sleeve and stem can be confirmed.However a definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on the replacement system, excessive patient weight and trauma to the joint replacement.Based on this investigation the need for corrective and preventative action is not indicated.The devices will be retained.Corrected data: d1, h3, h5, h6(health effect - clinical code, medical device problem code, type of investigation, investigation findings), h8.

• Brand Name: ACETABULAR CUP HAP SIZE 44/52
• 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 ; UK
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12540361
• MDR Text Key: 273574941
• Report Number: 3005975929-2021-00447
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552280
• UDI-Public: 03596010552280
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2013
• Device Model Number: 74122152
• Device Catalogue Number: 74122152
• Device Lot Number: 08HW18303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2008
• 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
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 51 YR
• Patient Sex: Male