MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TI LOW PROFILE SCREW 6.5X30MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Date 10/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item number p0463044 item name avan cmntd shell ss 44mm lot # 0000710631.Item number p0560044 item name avan insert 44/22 lot # 0000714004.Item number 163651 item name 22.2mm dia cocr mod hd std nk lot # 428170.Foreign report source: (b)(6).The device will not be returned for analysis, due to hospital policy; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03916.0001825034 - 2020 - 03920.0001825034 - 2020 - 03921.0001825034 - 2020 - 03923.

Event Description

It was reported patient underwent hip arthroplasty.Subsequently, patient was revised approximately 8 years later due to hip pain.Surgeon had xrays taken and showed movement of the cup and cage.Surgeon operated to remove cup and cage.Attempts have been made and additional information on the reported event is unavailable at this time.

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/corrected updated: d4; h2; h3; h4; h6 radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: advanced osteolysis of the right hip arthroplasty as noted with suspected loosening of the acetabular implant.A 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.

• Brand Name: TI LOW PROFILE SCREW 6.5X30MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10749424
• MDR Text Key: 213488804
• Report Number: 0001825034-2020-03922
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K082446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 103533
• Device Lot Number: 138500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2021
• 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): Hospitalization; Required Intervention