MAUDE Adverse Event Report: ZIMMER, INC. M/L TAPER FEMORAL PRESS-FIT STEM EXTENDED OFFSET; HIP PROSTHESIS

Catalog Number 65771100720

Device Problem Compatibility Problem (2960)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that following broaching for hip arthroplasty procedure, the femoral stem opened for implantation would not seat to the same height as prepared with the broaches.An alternate stem was used.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.No devices or photos were received; therefore the condition of the components is unknown.The device history records (dhr) for this implant lot was reviewed and found to be conforming at the time of manufacture.Dhr shows no anomalies or deviations that would have affected the surgical outcome or contributed to the reported event.This device is used for treatment of the patient.Complaint history search found that this was the only complaint for this part number.This was the only complaint for the part and lot combination as well.Surgical notes were not provided.X-rays were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.With the information provided, a definitive root cause cannot be determined.(b)(4).

• Brand Name: M/L TAPER FEMORAL PRESS-FIT STEM EXTENDED OFFSET
• Type of Device: HIP PROSTHESIS
• 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: 5911380
• MDR Text Key: 53395674
• Report Number: 0001822565-2016-02956
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK042337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 65771100720
• Device Lot Number: 63102994
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1