MAUDE Adverse Event Report: ZIMMER, INC. VERSYS FEMORAL BEADED FULLCOAT COLLARED STEM; HIP PROSTHESIS

Catalog Number 00784301406

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 report will be amended when our investigation is complete.

Manufacturer Narrative

This follow-up report is being filed to correct information.Device 1 of 2 reference mfr.Report: 0002648920-2016-03219.Medical 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

This follow up report is being submitted to relay additional information.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

This follow-up report is being submitted to relay additional information.Explant date n/a as device was not explanted.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 relevant to the reported event 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 BEADED FULLCOAT COLLARED STEM
• Type of Device: HIP PROSTHESIS
• 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 46582-0708 ; 5745273773
• MDR Report Key: 5930266
• MDR Text Key: 53971786
• Report Number: 0001822565-2016-03120
• Device Sequence Number: 1
• Product Code: LPH
• 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,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: 07/31/2021
• Device Catalogue Number: 00784301406
• Device Lot Number: 61786866
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2016
• Initial Date FDA Received: 09/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 06/26/2017; 12/01/2017
• Supplement Dates FDA Received: 10/18/2016; 03/05/2017; 06/30/2017; 12/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2011
• 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