MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 52/58; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74122158

Device Problems Biocompatibility (2886); Compatibility Problem (2960)

Patient Problems Injury (2348); Limited Mobility Of The Implanted Joint (2671); Metal Related Pathology (4530)

Event Date 10/17/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed on the patient right hip on (b)(6) 2018.The revision surgery was performed due to limited mobility, elevated metal ion levels, and metallosis.The patient outcome is unknown.

Manufacturer Narrative

It was reported that a revision surgery was performed on the patient right hip.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.Without definitive part/lot numbers a complete complaint history review cannot be performed for the devices involved.As no device batch numbers were provided for investigation, a manufacturing record review, ifu review could not be performed.The risk management review have been performed for the alleged failure mode.If more information is received, this investigation will be reopened.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this patient¿s particular case, our investigation remains inconclusive.No preventative or corrective action has been initiated as a result of this investigation.

Manufacturer Narrative

H10: additional information in a1, a2, a3, b5, b6, b7, d1, d4, g4, h4 and h6 (updated health effect - clinical code, health effect - impact code & medical device problem code).

Event Description

It was reported that a revision surgery was performed on the patient right hip on (b)(6)2018.The revision surgery was performed due to limited mobility, elevated metal ion levels, and metallosis.During the revision, both metallic components were explanted and replaced with tha system from a competitor.The patient outcome is unknown.The primary right hip bhr resurfacing surgery was performed on (b)(6) 2009.

Manufacturer Narrative

H3, h6: it was reported that a right hip revision surgery was performed.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 acetabular cup and the femoral head 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.No other complaints were identified to involve this batch for the acetabular cup.Other complaints were identified to involve this batch for the femoral head.Other similar complaints have been identified for the part number and the reported failure mode for the acetabular cup and the femoral head.This 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.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, no prior applicable escalation actions were identified.The available medical documents were reviewed.With the information provided the clinical root cause of the reported discomfort, elevated cobalt chromium levels, noises, and small fluid collection cannot be confirmed.It cannot be concluded the reported clinical reactions were associated with a malperformance of the implant.The patient impact beyond the discomfort, revision, and expected transient post-op convalescence period cannot be determined.Based on the information provided we cannot confirm or further investigate the reported complaint, 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 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: ACETABULAR CUP HAP SIZE 52/58
• 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: sarah freestone ; aurora house; spa park; UK CV31 3HL
• MDR Report Key: 10581737
• MDR Text Key: 208383609
• Report Number: 3005975929-2020-00355
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552310
• UDI-Public: 03596010552310
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2013
• Device Model Number: 74122158
• Device Catalogue Number: 74122158
• Device Lot Number: 08GW17824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2008
• 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
• Patient Age: 69 YR
• Patient Sex: Male