FDA Adverse Event Injury Summary report: N

ZMR HIP SYSTEM FEMORAL STEM

MDR report key: 2146473 · Received May 26, 2011

Report

Report Number: 1822565-2011-01253
Event Type: Injury
Date Received: May 26, 2011
Date of Event: April 22, 2011
Report Date: April 29, 2011
Manufacturer: ZIMMER, INC.
Product Code: LPH
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

INFO WAS RECEIVED VIA MEDWATCH USER FACILITY REPORT (B)(4). EVAL SUMMARY: NO OPERATIVE NOTES WERE INCLUDED. ONE X-RAY WITH POOR RESOLUTION WAS PROVIDED FOR REVIEW. THERE APPEARED TO BE A CRACK AT THE JUNCTION OF THE CONE BODY AND THE POROUS STEM. PROXIMAL BONE STOCK WAS NOT VISIBLE. THE PACKAGE INSERT AND/OR SURGICAL TECHNIQUE CONTAIN STATEMENTS WARNING THAT DEVICE FRACTURES MAY OCCUR WHERE EXCESSIVE PATIENT WEIGHT, EXCESSIVE PATIENT ACTIVITY, AND/OR LACK OF PROXIMAL SUPPORT ARE INVOLVED. GIVEN THE INFO PROVIDED AND THE RESULTS OF THE ANALYSIS, A DEFINITIVE CAUSE FOR THE EXPERIENCE OF STEM FRACTURE CANNOT BE DETERMINED WITH CERTAINTY. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

Description of Event or Problem · 1

IT IS REPORTED THAT THE PATIENT WAS REVISED. IT WAS FOUND THAT THE BODY PORTION HAD BROKEN FROM THE STEM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ZMR HIP SYSTEM FEMORAL STEM		LPH	ZIMMER, INC.		76133400V

Patients

Seq	Age	Sex	Outcome	Treatment
1	74 YR		Required Intervention	ZMR HIP SYSTEM FEMORAL BODY, CATALOG #00999302035\| LOT# 60140650