MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR NECK G 12/14 NECK TAPER USE WITH +0 HEADS ONLY LZO; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00771301000, modular femoral stem press-fit, 61813586, 00801803602, femoral head 12/14 taper, 61841705, 00630505036, liner standard 3.5 mm offset 36 mm i.D, (b)(6), 00620005422, shell porous with cluster holes 54 mm o.D., (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-03314.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during the revision surgery, the neck of the femoral stem was cold-welded to the stem, and therefore not removed.No additional information available.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: a5, b4, b5, b7, g4, g7, h2, h3, h6, h10.Reported event was confirmed by review of medical records.Review of the available records identified the following : the patient underwent an initial right total hip arthroplasty on (b)(6) 2011.Zimmer biomet products were implanted without any complications.The patient underwent a revision procedure on (b)(6) 2018 due to pain, loosening, periprosthetic fracture, elevated metal ion levels, comorbidities, hematoma, necrosis, in vivo corrosion, heterotopic ossification, difficulty ambulating, decrease in adls, pseudotumor, failure to osteointegrate, osteolysis, dislocation, adverse local tissue reaction, and instability.During revision it was noted that the femoral head was removed without difficulty from the trunnion.The female taper aspect of the head revealed no gross metallosis.The trunnion at this time revealed mild taper corrosion with no gross damage to the trunnion area.The neck of the femoral stem was cold-welded to the stem, and therefore not removed.The residual stem was determined to be stable both axially and rotationally.Review of the device history records identified no deviations or anomalies during manufacturing.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: MODULAR NECK G 12/14 NECK TAPER USE WITH +0 HEADS ONLY LZO
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8861921
• MDR Text Key: 153832577
• Report Number: 0001822565-2019-03337
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K063251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 00784802300
• Device Lot Number: 61680670
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Weight: 58