MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK FREEDOM CUP; PROSTHESIS HIP

Model Number N/A

Device Problem Disassembly (1168)

Patient Problems Cyst(s) (1800); Fall (1848)

Event Date 12/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event - (b)(6) 2016.Implant year - 2008.Explant year - 2016.Concomitant medical devices - unk freedom liner, unk femoral head, unk neck.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-03898.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during an office visit 4 years post the revision surgery to a hinge-knee, the doctor found that the external clamping ring had a rotational migration of 8° suggesting that the cup¿s locking-mechanism may have failed but the patient was asymptomatic.The surgeon let the patient go without any treatment.Ten (10) months post this diagnosis, the patient was revised due to fall and she heard a popping sound.It was also noted that she had 2 prior falls during this 10 month period.During the surgery it was found that the external clamping ring now had a rotational shift, small cystic areas were also visible behind the acetabular shell, the liner¿s polyethylene rim had been abraded and a large loose fragment was recovered and the femoral head had been making some contact with the metal acetabular shell.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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.

Manufacturer Narrative

Literature - successes and failures of a freedom constrained cup used in major salvage procedure.Reported event was confirmed by review of pictures of the device and x-rays provided.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.X-ray evaluation in the article shows the clamp ring was parallel with the cup.4 years follow up x-ray shows the clamp ring tilted 0.5 degree superiorly.8 years follow up x-rays show the clamp ring tilted 8 degree superiorly in ap view.X-ray 10 month after that show the angle increased to 14.3 degree.Ct scans showed the femoral head was in contact with the metal acetabular shell.Small cystic areas were also visible behind the acetabular shell.The surgeon surmised that the resulting contact with the repeatedly subluxing femoral head produced cold-flow and back-side wear in the polyethylene.Root cause was unable to 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 additional information received.

• Brand Name: UNK FREEDOM CUP
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7592741
• MDR Text Key: 110812132
• Report Number: 0001825034-2018-03899
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 68