MAUDE Adverse Event Report: ZIMMER, INC. UNK VERSYS HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problems Pain (1994); Osteolysis (2377); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The reported event was identified during review of a journal article author, theodoros balbouzis et al.Granulomatous lung disease following metallosis from hip arthroplasty.Event date is sometime in 2015.Device was implanted sometime in 2011.Device was explanted sometime in 2015.Stem revised is a competitor product.(b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.The following sections could not be completed with the limited information provided.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-02142.

Event Description

It was reported in a journal article that one patient was revised approximately 4 year post-implantation due to metallosis, high cobalt and chromium levels, osteolysis of the proximal femur, pseudo tumor, pain, decreased range of motion and polyethylene liner wear.The head, liner and stem were revised.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Reported event was unable to be confirmed as part number / lot number of device involved in the incident was unknown.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: UNK VERSYS HEAD
• Type of Device: PROSTHESIS, HIP
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6465371
• MDR Text Key: 72071368
• Report Number: 0001822565-2017-02141
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2017
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 76