MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER M/L KINECTIV NECK; HIP PROSTHESIS

Catalog Number 00784801401

Device Problem Corroded (1131)

Patient Problems Pain (1994); Reaction (2414); Fluid Discharge (2686)

Event Date 09/16/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported the patient was revised following a hip arthroplasty due to pain, nausea, and an mri which revealed elevated cobalt and chromium ion levels and the presence of a pseudotumor.During surgery, there was a significant amount of fluid discharge from the joint and corrosion between the head and neck trunnion.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products: 00801803602 femoral head 12/14 taper, lot # 61454985; 00875705201 shell with cluster holes porous 52 mm o.D.Size ii for use with ii liners, lot 61355467; 00771300600 modular femoral stem press-fit plasma sprayed cementless size 6, lot 61371875; 00875101036 liner neutral 36 mm i.D.Size ii for use with 52 mm o.D.Size ii shell, lot 61349741.Reported event was confirmed by review of the provided revision op notes.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required.Review of the revision op notes and surgeon follow up notes, the patient suffered from pain and elevated ions.A small pseudotumor around the greater trochanter area and corrosion was visible at the head junction.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.

Event Description

It is reported the patient was revised following a hip arthroplasty due to pain, wear, nausea, elevated cobalt and chromium ion levels, pseudotumor, and trunnionosis.During surgery, there was a significant amount of fluid discharge from the joint and corrosion between the head and neck trunnion.

• Brand Name: ZIMMER M/L KINECTIV NECK
• 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: kathleen smith ; p.o. box 708; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6048342
• MDR Text Key: 58098212
• Report Number: 0001822565-2016-03859
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK071856
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

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: 01/31/2018
• Device Catalogue Number: 00784801401
• Device Lot Number: 60872472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2016
• Initial Date FDA Received: 10/21/2016
• Supplement Dates Manufacturer Received: 11/27/2017
• Supplement Dates FDA Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2008
• 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: 58 YR