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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC.KINECTIV TECHNOLOGY MODULAR NECKHIP PROSTHESIS

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ZIMMER, INC. KINECTIV TECHNOLOGY MODULAR NECK HIP PROSTHESIS   Back to Search Results
Catalog Number 00784801300
Device Problem Device remains implanted
Event Date 06/19/2009
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description

It is reported by the patient that the device was implanted in 2008, and that post op, the patient has experienced pain in the groin area. Revision surgery has been recommended, but has not yet taken place.

 
Manufacturer Narrative

Evaluation summary: no product was returned for evaluation and the condition of the devices are unknown. It is unlikely that the kinectiv modular neck and m/l taper with kinectiv components contributed to the alleged event of acetabular component loosening and pain. The surgical notes from the primary surgery are unavailable, and it is unknown if the stem and neck were implanted with the correct orientation and correct fit as per surgical technique. X-ray images post-primary surgery and from successive patient visits are unavailable. The instruments used in the primary surgery are also unknown. Patient height, weight, and activity level are unknown. Factors which may contribute to acetabular loosening pertaining to the kinectiv modular neck and m/l taper with kinectiv components may be one or a combination of the following mechanism: improper neck length and offset, misalignment of femoral stem/neck assembly, extent of mating connectivity between stem/neck/head interfaces, impingement, or patient activity post-surgery. However, the exact cause for the current situation cannot be conclusively determined. Evaluation: no product was returned. Review of the device history records did not find any deviations or anomalies. It is not suspected that the product failed to meet specifications. The investigation could not verify or identify any evidence of product contribution to the reported problem. Based on the investigation, the need for corrective action is not indicated. Should additional substantive information be received, the complaint will be reopened. Zimmer, inc. Considers the investigation closed.

 
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Brand NameKINECTIV TECHNOLOGY MODULAR NECK
Type of DeviceHIP PROSTHESIS
Manufacturer (Section F)
ZIMMER, INC.
p.o. box 708
warsaw IN 46581 0708
Manufacturer (Section D)
ZIMMER, INC.
p.o. box 708
warsaw IN 46581 0708
Manufacturer Contact
brian fiedler
p.o. box 708
warsaw , IN 46581-0708
(800) 613 -6131
Device Event Key1489148
MDR Report Key1416796
Event Key1351080
Report Number1822565-2009-00815
Device Sequence Number1
Product CodeKWY
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 06/19/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/17/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date10/31/2017
Device Catalogue Number00784801300
Device LOT Number60782517
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Date Manufacturer Received06/19/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/17/2009 Patient Sequence Number: 1
#TreatmentTreatment Date
ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV
TECHNOLOGY MODULAR FEMORAL STEM PRESS-FIT
PLASMA SPRAYED
LOT #60831165
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