MAUDE Adverse Event Report: ZIMMER, TURPEAUX INDUSTRIAL PARK ZIMMER FEMORAL HEAD; JDI

Catalog Number 00902602300

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 08/25/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog #unk, unknown zimmer liner, lot #unk.This report will be amended when our investigation is complete.

Event Description

It is reported the patient underwent revision hip arthroplasty in 1995, and was recently revised due to the head wearing the liner down.

Manufacturer Narrative

No devices or photos were received; therefore the condition of the devices is unknown.Review of device history records for the head identified no deviations or anomalies in the manufacturing process.The lot number of the liner is unknown; therefore the device history records, complaint history could not be reviewed.The reported device is used for treatment.Review of complaint history identified no previous complaints for the part-lot combination associated with the reported head.It could not be confirmed if the devices were used in an approved and compatible combination.Surgical notes were not provided.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Relevant medical history and adherence to rehabilitation protocol are unknown.A definitive root cause cannot be determined with the information provided.

• Brand Name: ZIMMER FEMORAL HEAD
• Type of Device: JDI
• Manufacturer (Section D): ZIMMER, TURPEAUX INDUSTRIAL PARK; rt. #1, km 123.4; bldg. #1; mercedita PR 00715
• Manufacturer (Section G): TURPEAUX INDUSTRIAL PARK; rt. #1, km 123.4; bldg. #1; mercedita PR 00715
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5101154
• MDR Text Key: 26669270
• Report Number: 1822565-2015-01967
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Followup
• Report Date: 08/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00902602300
• Device Lot Number: 00690100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/1991
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR