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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ABGII. MODULAR STEM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALIC

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STRYKER ORTHOPAEDICS-MAHWAH ABGII. MODULAR STEM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALIC Back to Search Results
Catalog Number 4845-4-206
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Fall (1848); Bone Fracture(s) (1870); Injury (2348)
Event Date 06/03/2017
Event Type  Injury  
Manufacturer Narrative
An event regarding periprosthetic fracture involving a abg stem was reported. The event was confirmed. Device evaluation and results: not performed as the reported device was not returned for evaluation. Medical records received and evaluation: a medical review was performed and concluded: "this pi case is not device-related. A traumatic fall of the patient at 6-years post arthroplasty caused a periprosthetic fracture with subsequent subsidence of the stem requiring revision with fracture stabilisation about which no details are available" device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies. Complaint history review: review indicated there have been no other similar events for the reported lot. A medical review was performed and diagnosed that "a traumatic fall of the patient at 6-years post arthroplasty caused a periprosthetic fracture with subsequent subsidence of the stem requiring revision with fracture stabilisation about which no details are available" there was no evidence to indicate this was device related. No further investigation is required. If further relevant information becomes available or the product is returned, this investigation will be re-opened.
 
Event Description
Peri prosthetic fracture around an abg modular stem.
 
Manufacturer Narrative
It was noted that the device is not available for evaluation. Additional information has been requested. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
Peri prosthetic fracture around an abg modular stem.
 
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Brand NameABGII. MODULAR STEM
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALIC
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 Key6675864
MDR Text Key130065274
Report Number0002249697-2017-02061
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092406
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/01/2016
Device Catalogue Number4845-4-206
Device Lot NumberG3003756
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2011
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: 06/28/2017 Patient Sequence Number: 1
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