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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 Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 10/07/2020
Event Type  Injury  
Manufacturer Narrative
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. 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. The following devices were also listed in this report: 19mm mod rev hip body/bolt stdcomponent level 9006-1-019; cat# 6276-1-019 ; lot# 51569301; unknown_product restoration modular conical 155 stem ; cat# unknown; lot# unknown; unknown_product mdm metal liner;n. Cat# unknown; lot# unknown; primary tritanium hemi solidback cup 54mm; cat# 500-03-54e; lot# r938kh; unknown_product 28 8 v40 metal head lot 52860603; cat# unknown; lot# unknown. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience. Device not available.
 
Event Description
As reported: "unknown pathology led to revision. In revision surgery the cone body did not dissociate from the conical stem. An extended trochanteric osteotomy was performed and the stem was removed and new implants of appropriate size etc were implanted. " spoke to rep. Surgeon reported a suspicion of loosening prior to revision. Intra-operatively, surgeon noted the shell was osseointegrated, and the stem was fixed to the point where removal was difficult. The patient's entire hip construct was revised. Rep confirmed that no further information will be released by the hospital or surgeon.
 
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Brand NameRESTORATION ADM X3 INS 28/48
Type of DevicePROSTHESIS, 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 Key10770225
MDR Text Key214102987
Report Number0002249697-2020-02296
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093644
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 11/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2020
Device Model Number1236-2-848
Device Catalogue Number1236-2-848
Device Lot Number53484601
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/15/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/02/2020 Patient Sequence Number: 1
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