MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER SHELL; HIP PROSTHESIS

Device Problems Failure To Adhere Or Bond (1031); Fracture (1260)

Patient Problem No Information (3190)

Event Date 03/11/2014

Event Type  Injury  

Event Description

It is reported that the pt was revised due to loosening, broken screw and a broken ceramic cup.

Manufacturer Narrative

Eval summary: neither operative notes nor x-rays have been returned for review.The component fit and orientation per the surgical technique is unk.In general, pt factors that may affect the performance of the components include: age, bone quality, height/weight, activity level, type of activity (low impact vs.High impact), and relevant medical history.Rehabilitation and adherence thereto is unk.With the info provided, a definitive root cause cannot be determined.Eval: review of the device history records was not possible as the product and/or lot numbers required for retrieval were unavailable.It is not suspected that the product failed to meet specification.The investigation could not verify or identify any evidence of product contribution to the reported problem.Based on the available info, the need for corrective action is not indicated.Should additional substantive info be received, the complaint will be reopened.Zimmer, inc.Considers the investigation closed.

• Brand Name: ZIMMER SHELL
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; po box 708; warsaw IN 46581 070
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 3893681
• MDR Text Key: 4678400
• Report Number: 1822565-2014-00733
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN ZIMMER SCREW: CATALOG # UNK, LOT# UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 75