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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, CALICU
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STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU Back to Search Results
Model Number 1236-2-848
Device Problems Degraded (1153); Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Patient Problems Joint Dislocation (2374); Insufficient Information (4580)
Event Date 04/25/2023
Event Type  Injury  
Event Description
This pi is event 2.Second revision surgery on (b)(6) 2023.Bone head center position was obviously wrong on the reline and the sliding surface was moving strangely.Surgeon found that the adm insert was deformed/worn during surgery.Finished the revision surgery with competitor device on (b)(6) 2023.
 
Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.Device not returned to the manufacturer.
 
Manufacturer Narrative
Reported event: an event regarding dislocation and wear involving an adm liner was reported.The event was confirmed via evaluation of the returned device and clinician review of the provided medical records.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the rim of the inner diameter of the liner is slightly deformed.Minor scratches are observed in the inner diameter.The observed surface characteristics appear consistent with damage sustained from the dislocation event and/or the explantation attempt.This damage is also visible in the intraoperative photo that was provided.-clinician review: a review of the provided medical information by a clinical consultant indicated: "conclusion/assessment: revision surgery performed first for mom-altr then for a presumed intra-prosthetic dislocation or subluxation.Event confirmation: eccentric position of the femoral head can be confirmed from the x-rays.The implants and reasons leading to the event cannot be confirmed.Root cause: the root cause cannot be confirmed." -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 revised due to "the sliding surface moving strangely." wear/deformation of the adm poly liner was also observed intra-operatively.Visual inspection of the returned device indicated that the rim of the inner diameter of the liner is slightly deformed.Minor scratches are observed in the inner diameter.The observed surface characteristics appear consistent with damage sustained from the dislocation event and/or the explantation attempt.This damage is also visible in the intraoperative photo that was provided.A review of the provided medical information by a clinical consultant indicated: "conclusion/assessment: revision surgery performed first for mom-altr then for a presumed intra-prosthetic dislocation or subluxation.Event confirmation: eccentric position of the femoral head can be confirmed from the x-rays.The implants and reasons leading to the event cannot be confirmed." the intraoperative photo provided shows the adm liner articulating within part number 172501, metal on metal cup 50mm cup for 42mm head.The surgical protocol relevant to the adm liner, mdm-sp-1_rev-3_29426, does not reference part number 172501 as a compatible device.Mdm liner 626-00-42e is listed as the compatible device in which adm liner 1236-2-848 is intended to articulate.It is likely that the event is the result of off label use, but this cannot be confirmed without documentation regarding the instructions for use / surgical protocol for part number 172501.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.
 
Event Description
This pi is event 2.Second revision surgery on (b)(6) 2023.Bone head center position was obviously wrong on the reline and the sliding surface was moving strangely.Surgeon found that the adm insert was deformed/worn during surgery.Finished the revision surgery with competitor device on (b)(6) 2023.
 
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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
arokiya raj
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key16961099
MDR Text Key315547455
Report Number0002249697-2023-00564
Device Sequence Number1
Product Code MEH
UDI-Device Identifier04546540638977
UDI-Public04546540638977
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K093644
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 07/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/29/2024
Device Model Number1236-2-848
Device Catalogue Number1236-2-848
Device Lot Number70602401
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/15/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/20/2019
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 Age77 YR
Patient SexFemale
Patient Weight50 KG
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