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

Catalog Number 00801803602

Device Problem Detachment Of Device Component (1104)

Patient Problem Joint Dislocation (2374)

Event Date 09/13/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported that the patient experienced recurring dislocation.Upon x-ray, it was noted that the femoral head was detached from the femoral component.The patient was revised.

Manufacturer Narrative

The devices were returned for evaluation.The stem taper had signs of wear.The neck of the stem had signs of impingement.There were tissues ingrown on the beaded surface.The head had scrape marks on the articulating surface most likely from multiple dislocations.The female taper had black debris on the inside of it.The liner has a large gouge on the articulating surface most likely from the stem articulating on it after the head had disassociated from the stem.The shell had wear marks from some type of rubbing on the rim surface most likely from the dislocation and disassociation of the head.The device history records have been reviewed and did not identify any deviations/anomalies.These devices are used for the treatment of the patient.There are no other complaints for the device part and lot combination listed in this complaint.The patient had been noted to have two prior dislocations before this occurrence of dislocation with t he femoral head disassociating from the stem.With the provided information it is likely that the femoral head had loosened over the prior two dislocations which allowed the femoral head to disassociate during the latest dislocation.However, a definitive root cause for the dislocation could not be identified.

• Brand Name: VERSYS 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: 5131384
• MDR Text Key: 27702775
• Report Number: 2648920-2015-00361
• 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: 09/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 00801803602
• Device Lot Number: 6162310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2010
• 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: 45 YR