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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/54; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
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STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/54; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU Back to Search Results
Model Number 7236-2-854
Device Problems Unstable (1667); Detachment of Device or Device Component (2907)
Patient Problem Ambulation Difficulties (2544)
Event Date 04/13/2023
Event Type  Injury  
Event Description
As reported: "the revision on (b)(6) 2022 was of a right [competitor] total hip for instability.The revision today was also due to instability.It was discovered that the [competitor] ceramic head had disassociated from the mdm polyethylene insert.A stryker constrained liner and new [competitor] head were implanted today.No further information available from the surgeon or hospital.
 
Manufacturer Narrative
Reported event: an event regarding disassociation involving an adm liner was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.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 revision on (b)(6) 2022 was of a right [competitor] total hip for instability.The revision today was also due to instability.It was discovered that the [competitor] ceramic head had disassociated from the mdm polyethylene insert.A stryker constrained liner and new [competitor] head were implanted today'.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.Device not returned.
 
Manufacturer Narrative
Reported event: an event regarding disassociation involving an adm liner was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant indicated: 'the ap pelvis x-rays dated (b)(6) 2023 and (b)(6) 2023 show bilateral pressfit thas.The right tha in these x-rays has a constrained acetabular liner.The (b)(6) 2023 ap pelvis x-ray demonstrates that the right hip has dislocated.The acetabular constrained liner, along with the head and stem has dislocated from the shell.It is confirmed the patient had a tha with constrained liner and that this liner dissociated from the acetabular component in a tha dislocation.These findings are consistent with recurrent instability.The root cause for the recurrent instability cannot be ascertained from this limited documentation.' 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 revision on (b)(6) 2022 was of a right [competitor] total hip for instability.The revision today was also due to instability.It was discovered that the [competitor] ceramic head had disassociated from the mdm polyethylene insert.A stryker constrained liner and new [competitor] head were implanted today'.A review of the provided medical records by a clinical consultant indicated: 'the ap pelvis x-rays dated (b)(6) 2023 and (b)(6) 2023 show bilateral pressfit thas.The right tha in these x-rays has a constrained acetabular liner.The (b)(6) 2023 ap pelvis x-ray demonstrates that the right hip has dislocated.The acetabular constrained liner, along with the head and stem has dislocated from the shell.It is confirmed the patient had a tha with constrained liner and that this liner dissociated from the acetabular component in a tha dislocation.These findings are consistent with recurrent instability.The root cause for the recurrent instability cannot be ascertained from this limited documentation.' further information such as return of the device, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
As reported: "the revision on (b)(6) 2022 was of a right [competitor] total hip for instability.The revision today was also due to instability.It was discovered that the [competitor] ceramic head had disassociated from the mdm polyethylene insert.A stryker constrained liner and new [competitor] head were implanted today.No further information available from the surgeon or hospital.
 
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Brand Name
RESTORATION ADM X3 INS 28/54
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
anna ryan
raheen business park
limerick NA
EI   NA
61498200
MDR Report Key16898484
MDR Text Key314862448
Report Number0002249697-2023-00485
Device Sequence Number1
Product Code MEH
UDI-Device Identifier07613327315820
UDI-Public07613327315820
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182468
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/30/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number7236-2-854
Device Catalogue Number7236-2-854
Device Lot Number89044701
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/03/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/27/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age66 YR
Patient SexMale
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