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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION(TM) ADM. PRESS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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STRYKER ORTHOPAEDICS-MAHWAH RESTORATION(TM) ADM. PRESS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 1235-0-008
Device Problems Component Missing; Manufacturing, Packaging or Shipping Problem
Event Date 10/06/2017
Event Type  Malfunction  
Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

 
Event Description

The customer reported that the restoration adm press is missing a small pin or screw that holds it together. A stryker sales rep found the green plastic end fell of the instrument. The surgeon had to improvise a way of clamping the head and mdm poly insert together using the rest of the clamp and various other pieces of generic kit. This was eventually achieved. There was a surgical delay of approximately 10 minutes.

 
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Brand NameRESTORATION(TM) ADM. PRESS
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
Manufacturer Contact
brian lauro
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key6999462
Report Number0002249697-2017-03198
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/15/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/03/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number1235-0-008
Device LOT NumberG3257913
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/02/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/17/2012
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 11/03/2017 Patient Sequence Number: 1
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