MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. VERSYS FEMORAL HEAD; HIP PROSTHESIS

Catalog Number 00801804001

Device Problems Corroded (1131); Material Erosion (1214); Material Fragmentation (1261)

Patient Problems Pain (1994); Reaction (2414)

Event Date 11/17/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported the patient is experiencing pain following a hip arthroplasty and will have to have another surgery.She also claims the head is disintegrating and metal is floating around her body.

Manufacturer Narrative

This follow-up report is being filed to correct information.Device 2 of 2.Reference mfr.Report: 0001822565-2016-03120.Concomitant products: item: 00630506040, liner standard 3.5 mm offset 40 mm i.D.For use with 60 mm o.D.Shell, lot: 61412929.Item: 00620206020, shell porous with multi holes 60 mm, lot:61544771.Item: 00223200418, cable cerclage cable with crimp 1.8 mm dia.635 mm length, lot: 61790722.Item: 00223200418, cable cerclage cable with crimp 1.8 mm dia.635 mm length, lot: 61840691.Item: 00625006530, bone screw self-tapping 6.5 mm dia.30 mm length, lot: 61840691.Item: 00625006530, bone screw self-tapping 6.5 mm dia.30 mm length, lot: 61861611.Item: 00625006515, bone screw self-tapping 6.5 mm dia.15 mm length, lot: 61825067.Item: 00625006515, bone screw self-tapping 6.5 mm dia.15 mm length, lot: 61836012.

Manufacturer Narrative

No devices or photos of the devices were received; therefore, the condition of the components is unknown.Additionally, visual and dimensional evaluations could not be performed.The product number and the lot number were not provided; therefore, the manufacturing date, the device history records and the field age of the device could not be determined.There is insufficient information to perform a complaint history search.A definitive root cause could not be determined, as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that a patient was revised due to pain, accumulation of fluid, after opening, corrosion was found.Metal head was replaced with ceramic head and sleeve.Attempts have been made and no further information is available.

Manufacturer Narrative

Fluid buildup and metal debris was confirmed through review of doctor office notes and medical records.Reason for revision cannot be confirmed without revision operative notes.Medical notes from (b)(6) 2016 noted that patient reports left lateral thigh pain and complaints of walking with a limp.The patient states they have severe discomfort.Left hip aspiration from (b)(6) 2016 noted metal ion levels for chromium of 2.9 and cobalt of 18.7.Mri of the left hip showed a fluid collection and torn gluteus minimus.She reports that she continues to ambulate with a limp and uses a cane for assistance.Patient reports doing physical therapy and she feels is helping improve her limp slightly.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: VERSYS FEMORAL HEAD
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6036772
• MDR Text Key: 57730209
• Report Number: 0002648920-2016-03219
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/02/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 00801804001
• Device Lot Number: 61865234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2016
• Initial Date FDA Received: 10/18/2016
• Supplement Dates Manufacturer Received: Not provided; 06/26/2017; 12/01/2017
• Supplement Dates FDA Received: 03/05/2017; 06/30/2017; 12/02/2017
• 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): Other
• Patient Age: 77 YR