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

Catalog Number 00801803201

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Arthritis (1723); Cyst(s) (1800); Unspecified Infection (1930); Laceration(s) (1946); Damage to Ligament(s) (1952); Pain (1994); Joint Swelling (2356); Ambulation Difficulties (2544); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Other device used: catalog #00875100932, continuum highly crosslinked liner, lot #62130943, manufactured by zimmer (b)(4); catalog #00786401200, tm femoral stem, lot #62141583, manufactured by zimmer (b)(4); catalog #00875705001, continuum shell with cluster holes, lot #62146406, manufactured by zimmer (b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported that a patient suffered a variety of injuries such as dislocation, ligament tear, baker's cysts, joint effusion, and bone marrow signal changes in her right knee.The patient also has difficulty ambulating, exacerbation of lower back and osteoarthritis, infection and will need a hip replacement revision surgery.

Manufacturer Narrative

No devices or photos were received since the devices still remain implanted; therefore the condition of the components is unknown.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Patient activity level and adherence to rehabilitation protocol is unknown.Fda recall z-1031-2014 contains the related femoral head lot number 62175268.Recall was done since it was determined that the packaging operations were not properly validated; however the seal integrity testing conducted by zimmer confirmed that the packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays.A definite root cause cannot be determined with the information provided.These devices are used for treatment.

• Brand Name: VERSYS FEMORAL HEAD
• Type of Device: LPH
• Manufacturer (Section D): ZIMMER, TURPEAUX INDUSTRIAL PARK; rt. #1, km 123.4; bldg. #1; mercedita PR 00715
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46582-0708 ; 8006136131
• MDR Report Key: 5303065
• MDR Text Key: 33658559
• Report Number: 2648920-2015-00433
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/24/2015

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: 09/30/2022
• Device Catalogue Number: 00801803201
• Device Lot Number: 62175268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2015
• Initial Date FDA Received: 12/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1031-2014
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention