MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: zimmer femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 5 extended offset, cat#: 65771100520, lot#: 62411166.Zimmer femoral head sterile product do not resterilize 12/14 taper, cat#: 00801803602, lot#: 62424353.Zimmer shell porous with cluster holes 50 mm, cat#: 00620205022, lot#: 62479347.Zimmer liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells, cat#: 00630505036, lot#: 62449620.Zimmer bone scr 6.5x30 self-tap, cat#: 00625006530, lot#: 62389087.The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2020 - 00361.

Event Description

It was reported the patient underwent initial total right hip arthroplasty.Approximately 7 years post implantation, our legal counsel was notified of an unspecified claim.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

It was reported that the patient had an initial right tha.Despite undergoing a left hip revision six year later due to metal related pathology, the patient continues to experience elevated metal ion levels.No additional information is available.

Manufacturer Narrative

(b)(4).Reported event was confirmed by medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.The patient underwent an initial tha of the right and left side, a few months apart, both due to degenerative arthritis.The left tha was revised on due to metal related issues.Blood test results taken after the revision revealed elevated cobalt levels of 8.5, 6.9, and 6.7, respectively.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.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10351967
• MDR Text Key: 201549478
• Report Number: 0001822565-2020-02743
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K192660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 65771100520
• Device Lot Number: 62411166
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Other