MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SEE H10 NARRATIVE; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Detachment of Device or Device Component (2907); Unintended Movement (3026)

Patient Problems Host-Tissue Reaction (1297); Reaction (2414)

Event Date 10/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 16.25 standard offset.Concomitant medical products: 00801804005 femoral head 12/14 taper 60692252, 00630506240 liner standard 3.5 mm offset 60790067, item #: unknown cup lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2019 - 00813 head, 0001822565 - 2019 - 04762 liner.

Event Description

It was reported that the patient had a left total hip and subsequently had a revision surgery twelve years later.The patient had fluid around the hip joint and a large pseudo tumor.On x-ray it was observed that the femoral head had disassociated from the mlt stem.The trunnion of the stem was damaged and deformation.The top of the stem was resting up against the acetabular component.There was also black staining of the surrounding tissue.The liner was damaged.Attempts were made to obtain additional information; however, none was available.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).Complaint sample, radiographs and photographs were evaluated and the reported event was confirmed.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.A femoral head, m/l taper stem, and a trilogy liner were returned.The liner was most likely damaged due to the stem's taper pushing and rubbing against it.Therefore, no evaluation or dimensional analysis was performed for the liner.Visual inspection of the head identified black staining in the taper.The taper also exhibited nicks, gouges, and deformation.No other damages were noted.Visual inspection of the stem identified gouges, nicks, scratches, and deformation on the taper surface.Sem analysis of the femoral head revealed deposits on the taper surface and circumferential grooves, possibly from contact with the surface texture of the stem's taper.Axial wear or corrosion marks and light surface pitting were also visible on the taper's surface.Quantitative eds of the taper's surface identified biological material containing some or all of c, o, p, s, cl, and ca.Cocrmo substrate material showing elevated levels of cr, mo, and o, possible evidence of corrosion products.Eds analysis of the polished bearing surface of the head was consistent with cocrmo alloy.Radiographs identified disassociation at the junction of the femoral head and femoral neck.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: SEE H10 NARRATIVE
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9294041
• MDR Text Key: 165948546
• Report Number: 0001822565-2019-04764
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K161830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 65771101600
• Device Lot Number: 60500980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 87