MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED CEMENTLESS SIZE 6 STANDARD; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Discolored (1170); Material Erosion (1214)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Date 04/25/2022

Event Type  Injury  

Event Description

It was reported a patient underwent a left hip arthroplasty.Subsequently, mri showed fluid in left hip.Patient complained of pain.Coblat and chromium levels were elevated.Patient was revised approximately fifteen (15) years post implantation.Head was removed and showed some discoloration.Trunnion of the mlt stem showed some build up of corrosion and was discolored.A new liner and a head were re-implanted.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Concomitant medical products: cat#00620005222 shell porous with cluster holes 52 mm o.D.Lot#60802339, cat#00625006530 bone scr 6.5x30 self-tap lot#60808940, cat#00625006520 bone scr 6.5x20 self-tap lot#60808917, cat#00625006525 bone scr 6.5x25 self-tap lot#60838365, and cat#00630505032 liner standard 32 mm i.D.For use with 50/52/54 mm o.D.Shells lot#60784894.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: 0002648920-2022- 00131.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6 proposed component code: mechanical (g04) ¿ stem.Provided picture of the stem identified discoloration on the trunnion.No further evaluation can be made from the provided picture as the device is covered in bio-debris.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: anatomic alignment of the left hip arthroplasty.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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

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

• Brand Name: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED CEMENTLESS SIZE 6 STANDARD
• 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: 14460832
• MDR Text Key: 292718768
• Report Number: 0001822565-2022-01504
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 00771100600
• Device Lot Number: 60753349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2007
• 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
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 76 KG