MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 50MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120150

Device Problems Loss of Osseointegration (2408); Biocompatibility (2886); Migration (4003)

Patient Problems Pocket Erosion (2013); Osteolysis (2377); Metal Related Pathology (4530); Implant Pain (4561)

Event Date 04/15/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Us legal.It was reported that the plaintiff underwent a revision surgery of the right hip on (b)(6) 2019 due to pain, elevated metal ion levels and suspected metal debris.The outcome of the patient is unknown.The primary right bhr surgery was performed on (b)(6) 2009.

Event Description

It was reported that the plaintiff underwent a revision surgery of the right hip on (b)(6) 2019 due to pain, elevated metal ion levels and suspected metal debris.During the revision moderate to severe periprosthetic femoral neck osteolysis with erosion of the femoral neck under the resurfacing femoral component was noticed, as well as a moderate sized osteolytic defect posterior to the acetabulum.The metallic cup and femoral head were explanted and replaced with a tha system from a competitor.The patient tolerated the procedure well and was taken to the recovery room in good condition.The primary right bhr surgery was performed on (b)(6) 2009.

Manufacturer Narrative

Internal reference number: (b)(4).

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, 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 can be performed.If the products or additional information become available in the future, the tasks will be reopened and performed.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.Although it was reported the patient had elevated metal ions, neither the levels nor the lab reports were provided for review.Without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported pain and elevated metal ion levels cannot be confirmed.However, the patient¿s comorbidities and ¿grossly retroverted and somewhat vertical¿ acetabulum cannot be ruled out as a contributory factor of the reported clinical reactions.Without the return of the devices used in treatment or additional information we cannot advance the investigation or confirm this 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, loosening of components.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.

Manufacturer Narrative

H10: additional information in h7 and h9.H9: the concomitant product was also recalled.Fda recall - z-2745-2015 for 74121142 / resurfacing femoral head 42mm / lot# 086332.H3, h6.It was reported that a right hip revision surgery was performed due to pain, elevated metal ion levels (chromium = 3.3 g/ml) and suspected metal debris.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 devices concerned 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 cup and the head.This will continue to be monitored via routine trending, however it should be noted that these devices are no longer sold.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 pain and elevated metal ion levels cannot be confirmed.However, the patient¿s comorbidities and ¿grossly retroverted and somewhat vertical¿ acetabulum cannot be ruled out as a contributory factor of the reported clinical reactions.It is noted, 72 days post revision, the patient was ¿doing great with the right revision total hip.¿ 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.

Event Description

It was reported that, after undergoing right hip bhr resurfacing surgery on (b)(6) 2009 due to advanced post-traumatic hip degenerative joint disease, the patient experienced pain, elevated metal ion levels (chromium = 3.3 g/ml) and suspected metal debris.These conditions were treated by performing a revision surgery on (b)(6) 2019, in which moderate to severe periprosthetic femoral neck osteolysis with erosion of the femoral neck was found under the resurfacing femoral component.In addition, moderate sized osteolytic defect was noticed posterior to the acetabulum.Both the metallic cup and femoral head were explanted and replaced with a competitor¿s tha system (zimmer-biomet).The patient tolerated the procedure well and was taken to the recovery room in good condition.

Manufacturer Narrative

H10 ¿ additional information b5- describe event or problem b6- relevant tests b7- other relevant history d4 - catalog number, lot number, expiration date, unique identifier (udi) # g4 - pma/510(k)number h4 - device manufacture date h11 ¿ corrected data b2- outcomes attributed to adverse event d1- brand name e1- initial reporter name and address g2- report source h6- evaluation codes.

• Brand Name: ACETLR CUP HAP 50MM W/ IMPTR
• 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: 13242370
• MDR Text Key: 283749647
• Report Number: 3005975929-2022-00011
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502568
• UDI-Public: 3596010502568
• 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,Consumer,Health Professional,User Facility
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2012
• Device Catalogue Number: 74120150
• Device Lot Number: 70564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2007
• 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-2746-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male