MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ABGII MODULAR LONG NECK; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Catalog Number 4845-4-417

Device Problems Material Erosion (1214); Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 08/16/2014

Event Type  Injury  

Manufacturer Narrative

The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.

Event Description

1st dislocation.(b)(6) has benefited from a first implantation of total hip prosthesis left hip on (b)(6) 2010.Indeed in his operative report, the orthopaedist mentioned a painful stiffness on a disabling advanced coxarthrosis.A release and total hip arthroplasty had been performed with the installation of a cementless abg prosthesis with a ceramic couple, and acetabular autograft.The operation and the after-effects were simple.The iconographic control on (b)(6) 2010 was quite satisfactory with a good orientation of the acetabulum and the stem in the femoral shaft.On these pictures we can see a right coxarthrosis with a clear pinch, osteophytosis and slight flattening of the head.The patient indicates that he had benefited from walking with two english canes for about 15 days and then one cane for 15 days.He had had 2 or 3 months of rehabilitation afterwards.The iconographic controls had been satisfactory and he presented me with pictures on (b)(6) 2010.On (b)(6) 2014 radiographs of the frontal pelvis with ultrasound of the left hip were taken.There was synovial thickening without effusion.These examinations had been carried out at the request of doctor (b)(6) following a letter of information concerning the recalls of prostheses due to adverse effects (letter of information on (b)(6) 2013).(b)(6) specified that at that time he had no cane.The (b)(6) 2014 in (b)(6), one notes a first episode of dislocation of the total prosthesis of left hip.(b)(6) was sitting on a low wall and while going down one reports this dislocation.He was hospitalised from (b)(6) 2014.On leaving the hospital, the patient walked with two walking sticks for 15 days and then one walking stick for the next 15 days.(b)(6) stated that he had about 15 days of lmwh as a preventive measure.On examination of the images, it was an anterolateral dislocation.

Event Description

1st dislocation: (b)(6) has benefited from a first implantation of total hip prosthesis left hip on (b)(6) 2010.Indeed in his operative report, the orthopaedist mentioned a painful stiffness on a disabling advanced coxarthrosis.A release and total hip arthroplasty had been performed with the installation of a cementless abg prosthesis with a ceramic couple, and acetabular autograft.The operation and the after-effects were simple.The iconographic control on (b)(6) 2010 was quite satisfactory with a good orientation of the acetabulum and the stem in the femoral shaft.On these pictures we can see a right coxarthrosis with a clear pinch, osteophytosis and slight flattening of the head.The patient indicates that he had benefited from walking with two english canes for about 15 days and then one cane for 15 days.He had 2 or 3 months of rehabilitation afterwards.The iconographic controls had been satisfactory and he presented me with pictures on (b)(6) 2010.On (b)(6) 2014 radiographs of the frontal pelvis with ultrasound of the left hip were taken.There was synovial thickening without effusion.These examinations had been carried out at the request of doctor adrian following a letter of information concerning the recalls of prostheses due to adverse effects (letter of information on (b)(6) 2013).(b)(6) specified that at that time he had no cane.The (b)(6) 2014 in dieppe, one notes a first episode of dislocation of the total prosthesis of left hip.(b)(6) was sitting on a low wall and while going down one reports this dislocation.He was hospitalised from (b)(6) 2014.On leaving the hospital, the patient walked with two walking sticks for 15 days and then one walking stick for the next 15 days.Mr.Sot stated that he had about 15 days of lmwh as a preventive measure.On examination of the images, it was an anterolateral dislocation.

Manufacturer Narrative

Reported event: an event regarding alter involving abg ii modular neck was reported.The event was not confirmed.Method & results: device evaluation and results: device evaluation was not performed as device remains implanted.Device history review: review of device history records found the devices in the reported lot were accepted into final stock with no reported discrepancies.Complaint history review: the complaint databases show there have been two events for the reported lot related to the same device/patient.Similar events have occurred for the catalog number and product family.These events were determined to be associated with ra 2012-067.Clinician review: a review of the provided medical records and/or x-rays by a clinical consultant indicated: translated summary of events related to left hip: ".(b)(6) 2012 stryker initiated recall.Abg ii modular.Notified surgeons.Screening test.Metal ions." translated revision op note :".Remove modular neck.Which presents.Significant signs of corrosion.Excise.Pseudo tumor tissue.Blackish.Remove stem with osteotomes.Acetabular reconstruction with a double acetabulum." components changed to revision components by corin.No clinical or pmh, no primary tha op report, no imaging studies, no lab or surgical pathology reports, no baseline values for cobalt levels, no examination of explanted components.Based upon the translated summary of the medical history of this case involving the left hip, and the absence imaging studies, pathology reports and examination of explanted components, confirmation of the event descriptions or preparation of a medical report is not possible for this case.Conclusions: voluntary recall ra 2012-067 was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices.The reported revision due to pseudotumoral mass is considered to be under the scope of this recall.No further investigation is required.H3 other text : device not returned.

• Brand Name: ABGII MODULAR LONG NECK
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10007352
• MDR Text Key: 189498482
• Report Number: 0002249697-2020-00828
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K092406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2014
• Device Catalogue Number: 4845-4-417
• Device Lot Number: G2688071
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2090-2012
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 92