MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ZIMMER ACETABULAR SHELL; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Reaction (2414)

Event Date 10/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Medical product: versys hip system femoral head, catalog#: 00801803203, lot#: 60411224 unknown zimmer m/l taper femoral stem, catalog#: ni, lot#: ni standard liner, catalog#: 00630505632, lot#: ni.Complaint sample was evaluated and the reported event was confirmed.The following explanted devices where returned: head, liner.The liner has certain portion of the rim feature missing.The witness marks and surface of the fragmented pieces of the liner indicates extraction damage.Damage is too severe on the liner for dimensional analysis to be performed.The femoral head is returned with minor scratches and scuff marks on the articulating surface.The conical taper exhibits dark debris.Dimensional measurements of the head are conforming to print specifications, where measured.Eds analysis of the dark debris on the femoral head taper, confirms corrosion.Eds semi-quantitative elemental analysis of the base material indicated the elements c, o, si, ti, cr, mn, co, and mo.Eds analysis of the dark debris indicated the elements c, o, p, ti, cr, mn, co, and mo.The elements c, o, and p in the eds results of debris analysis could be from various sources including soft tissue and bone or dried biological fluids such as blood, etc.Ti element likely transfer from the stem taper while the concentrations of co, cr, si, mo and mn from the head.Review of the x-ray indicated steep acetabular cup lateral angle of inclination of approximately 47° which is a risk factor for superior polyethylene liner wear and hip dislocation.Radiolucency noted at superior lateral acetabular cup metal-bone interface is possible for acetabular cup loosening.Mild irregularity of metal is noted at the superior lateral acetabular cup in vicinity of implant designed open window which is of questionable significance in the setting of elevated cobalt levels.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2016-03273, 0001822565-2016-04126, 0001822565-2018-02550.

Event Description

It is reported that the patient's hip arthroplasty was revised due to elevated cobalt levels, pain and a pseudo tumor approximately 10 years post-implantation.In-vivo corrosion between head and stem was found upon explantation.Head and liner were revised.No further information has been provided.

• Brand Name: UNKNOWN ZIMMER ACETABULAR SHELL
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7495421
• MDR Text Key: 107920793
• Report Number: 0001822565-2018-02550
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• 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
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2018
• Initial Date FDA Received: 05/08/2018
• 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 Age: 55 YR
• Patient Weight: 81