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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNIVERSAL DRIVER SHAFT PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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STRYKER ORTHOPAEDICS-MAHWAH UNIVERSAL DRIVER SHAFT PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 2107-1015
Device Problems Component Missing; Adverse Event Without Identified Device or Use Problem
Event Date 05/10/2017
Event Type  Malfunction  
Manufacturer Narrative

The other devices listed in this report: cat. No. : 2208-4062, tritanium acetabular trial. Lot code: unknown. Cat. No. : 2107-1015, universal driver shaft, lot code: unknown. At this time, it cannot be determined if these devices may have caused or contributed to the patient¿s experience. Additional information has been requested and if received will be submitted in a follow up report upon completion of the investigation.

 
Event Description

A report to a company representative was in regard to the following event: during a revision surgery, the surgeon was unable to fix the acetabulum tritanium due to missing elements in the ancillary. The medical staff had to implant another device. This event caused intraoperative difficulties and lengthened the time of the intervention.

 
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Brand NameUNIVERSAL DRIVER SHAFT
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-MAHWAH
325 corporate drive
200 suhong road, sip
mahwah NJ 07430
Manufacturer Contact
brian lauro
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key6651164
Report Number0002249697-2017-01924
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation PHARMACIST
Type of Report Initial,Followup
Report Date 10/18/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/19/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number2107-1015
Device LOT NumberUNKNOWN
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 Received09/21/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 06/19/2017 Patient Sequence Number: 1
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