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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
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STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC Back to Search Results
Catalog Number 1236-2-848
Device Problem Noise, Audible (3273)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Injury (2348); Ambulation Difficulties (2544)
Event Date 12/04/2014
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
Patients friend called and stated that the patient had a left hip revision on (b)(6) 2014.She stated that patient was in pain since day one postop.Patient experienced pain, limited range of motion, would hear noises periodically and cant walk well.Patient had a revision on (b)(6) 2016.
 
Manufacturer Narrative
Device info added.The following devices were also listed in this report: c-taper cocr lfit head 28mm/+5, 06-2805; lot#mne54l.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An event regarding dislocation involving a adm liner was reported.The event was confirmed by medical review.Method & results: product evaluation and results: a material analysis has been performed.The report concluded: ¿the x3 insert was noted to have scratches, third body indentations, embedded debris, and explantation damage.The x3 insert also had damage consistent with impingement.The mobility insert and femoral head were observed to have scratches and explantation damage.The femoral head also had metal transfer debris within the female taper.Eds indicated the mobility insert and the femoral head to be consistent with astm fl 537.The adhered debris within the female taper was consistent with metal transfer between the stem and head.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined.¿ clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: ¿on (b)(6) 2016 a "revision of the left total hip arthroplasty, acetabular liner and head only'' for a diagnosis of "left hip dislocation, status-post primary and revision total hip arthroplasty" was performed.¿ ¿the patient's history of post-menopausal osteoporosis contributed to her fractures.The gamma nail construct functioned perfectly in situ resulting in healing of the stress fracture while maintaining its rigid fixation.The subsequent conversion to a total hip arthroplasty was indicated by progression of hip osteoarthritis.Two dislocations, indicating an unstable total hip arthroplasty, required revision to a more stable bearing construct like the mdm/adm bearing selected.Acetabular shell and stem are still retained as they have successfully osteointegrated.In the revision surgery of (b)(6) 2014 in which the mdm/adm bearing was implanted impingement of the joint was noted at the extremes of motion.The position of the well-fixed femoral and acetabular components were not changed, exposing the mdm/adm construct to the same impingement which was subsequently noted on the material analysis report of the explanted mdm/adm bearing.Dislocations are more common in revision surgery, and noting evidence of subsequent impingement evidence of the mdm/adm at revision would also cause instability.The revision to a constrained liner has apparently resulted in a stable hip as of the last documentation on (b)(6) 2018.Review of the medical records and material analysis report of the explanted components do not suggest component material or manufacturing factors as related to this clinical picture.¿ product history review: review of the product history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: the event for dislocation was confirmed.The patient was revised on (b)(6) 2016 for dislocation.As noted in the medical review, ¿two dislocations, indicating an unstable total hip arthroplasty, required revision to a more stable bearing construct like the mdm/adm bearing selected.Acetabular shell and stem are still retained as they have successfully osteointegrated.In the revision surgery of (b)(6) 2014 in which the mdm/adm bearing was implanted impingement of the joint was noted at the extremes of motion.The position of the well-fixed femoral and acetabular components were not changed, exposing the mdm/adm construct to the same impingement which was subsequently noted on the material analysis report of the explanted mdm/adm bearing.Dislocations are more common in revision surgery, and noting evidence of subsequent impingement evidence of the mdm/adm at revision would also cause instability.Review of the medical records and material analysis report of the explanted components do not suggest component material or manufacturing factors as related to this clinical picture.¿.
 
Event Description
Patients friend called and stated that the patient had a left hip revision on (b)(6) 2014.She stated that patient was in pain since day one postop.Patient experienced pain, limited range of motion, would hear noises periodically and cant walk well.Patient had a revision on (b)(6) 2016.Update per medical review: ¿on (b)(6) 2016 a "revision of the left total hip arthroplasty, acetabular liner and head only'' for a diagnosis of "left hip dislocation, status-post primary and revision total hip arthroplasty" was performed.The operative report notes, " intact sleeve of soft tissue encasing the joint 28 mm head was subluxated out of the polyethylene liner, which in turn was subluxated a bit out of the metal component of the acetabular liner hip was dislocated femoral component well-fixed well-positioned acetabular shell well-fixed and well-oriented changed to a 22/plus-5 head and a constrained liner ".
 
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Brand Name
RESTORATION ADM X3 INS 28/48
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 Key7415229
MDR Text Key105127260
Report Number0002249697-2018-01068
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
PMA/PMN Number
K093644
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 12/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/31/2019
Device Catalogue Number1236-2-848
Device Lot Number49157601
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2018
Date Manufacturer Received11/16/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age63 YR
Patient Weight52
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