MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Model Number 1236-2-848

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Neuropathy (1983); Pain (1994); Ambulation Difficulties (2544); Thrombosis/Thrombus (4440)

Event Date 08/14/2019

Event Type  Injury  

Event Description

This pi is for diagnosis of right distal lower extremity dvt on august 14, 2019 and ongoing treatment for continued pain and neuropathic symptoms below the right knee (loss of sensation and function).As reported in medwatch mw5092796: doctor replaced ball and socket components, originally placed in 2008.Right hip.Doctor stated that the sciatic nerve had been traumatized during the extended procedure to clear the damaged tissue and took over two hours longer.The right foot did not respond to physical therapy in the hospital, so i was released with an afp brace.Further, testimony and continued disability caused the doctor to "reattack" the damaged right hip from the rear on (b)(6) 2019.During this procedure scar tissue was removed from the sheath on the nerve manually through the 8 inch incision.Electric stimulator of the nerve caused toes to move.Still treatment for lower extremity blood clots and foot swelling continue into the sixth month, with minor improvement.Update (b)(6) 2020: "add'l info received [by fda] on 03/23/2020 from reporter for report mw5093848.Gentlemen: the items are my wife's request for a class 1 recall of stryker metal-on-metal hip head ball components.Included are her personal notes, dr.[.] surgical reports (3), dr.[.] pres-surgical comment, lab reports from [.] 2019 - [.] 2019, and her fda form 3500 submission.The fda was being asked to start the recall class 1, for the sake of other patients who might have the same corrosion caused metallosis.A report on webmd/v and a market publication of november 2014 show that over a billion dollars in federal court [.] have been paid by stryker for similar hip components, yet our doctor has not been notified of the recall.To date, [.], has been unable to use her right foot.After the [.] surgeries, with charges submitted to [.] and [.] - for life, the government asked the cause.We responded that it was metal corrosion from a stryker hip replacement of [.] 2008.We were instructed to wait upon the u.S treasury being made whole, before submitting our claim.Now, approaching nine months, requiring 24/7 care, we have asked the fda for the recall.Expecting that stryker would respond quickly to the government, we borrowed against our personal retirement accounts, for a used vehicle, and other disability support items.Fast forward into 2020, no response from our [.] attorney cause us to make the following: declare the class 1 recall; settle the current u.S government claims, and future claims related to it; considering how stryker corporation might replace our common stock losses from our retirement accounts.(this is not a litigation, because we are directed to await the government).(coronavirus market effects all of us with our holdings).

Manufacturer Narrative

An event regarding patient factors (dvt) involving an adm liner was reported.The event was confirmed via clinician review of the provided medical records.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.Clinician review: a review of the provided medical information by a clinical consultant indicated: "this patient underwent a primary total hip arthroplasty using cementless components in january 2008.Approximately 11 1/2 years later this patient required revision for what is described as corrosion at the head neck junction.A revision was carried out and unfortunately the patient sustained a fracture of the greater trochanter, and a complete sciatic nerve palsy and a dvt.I can confirm that the patient had both the primary procedure and the revision procedure since i was able to see x-rays with the implants in place.[.] i cannot confirm the root cause of this event with certainty.Causes of head neck corrosion are multifactorial including surgical technique factors, patient activity level and bmi, and implant factors.Causes of complete sciatic nerve palsy are also multifactorial but most likely involve surgical technique factors in either stretching or twisting of the nerve, direct compression of the nerve or in rare cases transection of the nerve which did not occur in this case.The causes of dvt are also multifactorial depending on the patient's activity level and medical condition as well as hematological and metabolic factors.[.] based upon my review of the three operation reports, my conclusion of assessment is unchanged.I can add that the revision procedure was performed through an anterior approach, which historically does result in more complications, including fractures, and nerve dysfunction." -product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was diagnosed with deep vein thrombosis post-implantation and is undergoing further physical therapy and prescription medication to address.No allegations were reported against the stryker devices, and they remain implanted in the patient.A review of the medical records by a clinician confirmed the event and indicated the following: "the causes of dvt are also multifactorial depending on the patient's activity level and medical condition as well as hematological and metabolic factors.[.] the revision procedure was performed through an anterior approach, which historically does result in more complications, including fractures, and nerve dysfunction." no further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.The following devices were also listed in this report: modular dual mobility insert; cat# 626-00-42e; lot# 67758503 trochanteric grip plate; cat# 6704-3-082; lot# g7519347 it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.H3 other text : not returned.

• Brand Name: RESTORATION ADM X3 INS 28/48
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16928817
• MDR Text Key: 315204224
• Report Number: 0002249697-2023-00514
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 04546540638977
• UDI-Public: 04546540638977
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 1236-2-848
• Device Catalogue Number: 1236-2-848
• Device Lot Number: 403881
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2018
• 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): Other
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 73 KG