MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN ZIMMER CALCAR PLANER; HIP INSTRUMENT

Device Problem Insufficient Information (3190)

Patient Problem Hip Fracture (2349)

Event Type  Injury  

Manufacturer Narrative

Information was received via published literature.Please reference http://www.Ncbi.Nlm.Nih.Gov/pubmed/20387021.

Event Description

It is reported that two fractures were identified intraoperatively in 18 hips, both occurred with the toothed design.Both fractures were type-2, minimally displaced calcar fractures.Extending to the level of the lesser trochanter.Both fractures were identified and treated intraoperatively with a single cerclage cable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

• Brand Name: UNKNOWN ZIMMER CALCAR PLANER
• Type of Device: HIP INSTRUMENT
• 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: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5725477
• MDR Text Key: 47396492
• Report Number: 0001822565-2016-02025
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2017
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention