MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TITANIUM SCREW LOW PROF 5X40MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Local Reaction (2035); Reaction (2414); Inadequate Osseointegration (2646)

Event Date 01/20/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: 15-105056-m2a 1 pc shell 38mmx56mm-831000; 11-173666-m2a 38mm mod hd +12mm nk skrt-140670; 14-103202-taperloc microp fmrl 7.5mm-374630.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 00398 - 1, 0001825034 - 2020 - 00399 - 1, 0001825034 - 2020 - 01925.Reported event was confirmed.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: (summarized by hcp).Dx: painful left tha, probable metallosis, broken fixation screw.Workup for infection negative, crp <5.0, metal ions elevated, mri showed fluid collection with an overall appearance of metallosis.Large amount of dark sanguineous fluid present, moderate metal staining in the synovial tissues and bone surface of the acetabulum, rim screw broken, scant if any osseous integration on the back of the acetabulum, femoral component well fixed.Modest to moderate wear on the trunnion and metallic debris within the femoral head suggested that trunnionosis was indeed the likely cause of metal debris.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

It was reported the patient underwent a revision surgery 12 years post implantation due to pain and suspected metallosis on mri.During the revision, significant black staining from trunnionosis was noted.The acetabular shell was replaced due to a broken rim screw and very little osseointegration on the back of the shell.The stem was well-fixed and left intact.All other components were replaced without complication.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Two screws were returned; upon visual inspection one screw head appears to be fractured and the other screw appears to be fine.The additional information does not change the outcome of the previous investigation.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 additional information on the reported event.

• Brand Name: TITANIUM SCREW LOW PROF 5X40MM
• 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: 10488577
• MDR Text Key: 205664316
• Report Number: 0001825034-2020-03423
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030710
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 113848
• Device Lot Number: 384740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2004
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male