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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. FEMORAL STEM SIZE 12.5 PROSTHESIS, HIP

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ZIMMER, INC. FEMORAL STEM SIZE 12.5 PROSTHESIS, HIP Back to Search Results
Catalog Number 00771101220
Device Problems Defective Component; Component or Accessory Incompatibility
Event Date 03/16/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4). Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that during a knee arthroplasty the femoral stem was too small to be press in the femoral canal after the surgeon reamed with a broach corresponding to the size of the stem. The surgeon reamed to a larger size and the component fit without issue. No additional patient consequences were reported.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Complaint sample was evaluated and the reported event was not confirmed. A m/l taper stem was returned for evaluation. As returned, the stem is in excellent condition. The stem was inspected on comparator confirming size in the a/p and m/l view. Device history record was reviewed and no discrepancies were found. Root cause was unable to be determined, as the reported event could not be substantiated. A summary of the investigation has been sent to the complainant. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.

 
Event Description

It was reported that during a total hip arthroplasty the femoral stem was allegedly too small to be press-fit into the femoral canal after the surgeon reamed with a broach corresponding to the size of the stem. The surgeon reamed to a larger size and the component fit without issue. No additional patient consequences were reported.

 
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Brand NameFEMORAL STEM SIZE 12.5
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw , IN 46582
5745273773
MDR Report Key6598945
Report Number0001822565-2017-03670
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/18/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/30/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue Number00771101220
Device LOT Number63186453
OTHER Device ID NumberSEE H10 NARRATIVE
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/01/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/17/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/13/2015
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: 05/30/2017 Patient Sequence Number: 1
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