MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN SCREW; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed.Review of the available records identified the following: the triflange acetabular implant is loose and several fixation screws are fractured.The acetabular implant is mildly displaced laterally.A single surgical screw is present within the soft tissues posterior to the proximal femur.There is advanced lower lumbar degenerative disc disease and mild retrolisthesis at what appears to be the l4-l5 level.The acetabular implant is loose as described and mildly displaced.Femoral implant fit is maintained and alignment of the femoral head within the cup is preserved.Bone quality is mildly osteopenic.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 01714, 0001825034 - 2020 - 03563, 0001825034 - 2020 - 03565.

Event Description

It was reported the patient underwent a surgery approximately two years ago.Subsequently, the patient's pmi triflange device has failed.The surgeon is requesting we look at possibilities for another triflange device, or alternative surgical options could be pursued to reconstruct this patient¿s acetabulum.X rays were provided and showed screws were fractured.Possible future revision, however no revision has been reported to date.No further event information available at the time of this report.

• Brand Name: UNKNOWN SCREW
• 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: 10546948
• MDR Text Key: 208188804
• Report Number: 0001825034-2020-03564
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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