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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 10/27/2020
Event Type  Injury  
Manufacturer Narrative
An event regarding revision for unspecified reason involving an adm liner was reported. The event was not confirmed. Method & results: product evaluation and results: not performed as no product was returned for evaluation. Medical records received and evaluation: no medical records were received for review with a clinical consultant. Product history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies. Complaint history review: there has been no other similar events for the lot referenced. Conclusions: the exact cause of the event could not be determined because insufficient information was provided. Additional information including the reason for revision surgery, operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event. If further information becomes available or the product is returned, this investigation will be re-opened. The following devices were also listed in this report: cat# 6519-1-028; delta un. Fem hd 28mm r28 16/18; lot# 79305701; cat# 19-0005t; uni adaptor sleeve c taper ti; lot# 77912102. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience. Not returned to the manufacturer.
 
Event Description
It was reported through the submission of a usage sheet that the patient's left hip was revised. In comparing the usage sheets from the current and previous revision, a 28/48 mm 42e adm/ mdm poly insert, 28 mm universal taper head, and +5mm c-taper adapter sleeve were all swapped to the same devices of the same size.
 
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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
joann lavatelli
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10867740
MDR Text Key217091702
Report Number0002249697-2020-02498
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,other
Reporter Occupation
Type of Report Initial
Report Date 11/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1236-2-848
Device Catalogue Number1236-2-848
Device Lot Number78624601
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 Received10/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2020
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: 11/19/2020 Patient Sequence Number: 1
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