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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. UNK FREEDOM LINER PROSTHESIS HIP Back to Search Results
Model Number N/A
Device Problems Disassembly; Fracture; Migration or Expulsion of Device; Naturally Worn; Noise, Audible
Event Date 12/09/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4). Date of event: (b)(6) 2016. Implanted date: implant year - 2012. Explanted date: explant year - 2016. Concomitant medical products: unk freedom cup ; unk femoral head; unk neck. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-03899. 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. 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.

 
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Brand NameUNK FREEDOM LINER
Type of DevicePROSTHESIS 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 Key7592755
Report Number0001825034-2018-03898
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,LITERATUR
Reporter Occupation
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 Received06/12/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/19/2018
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

Patient TREATMENT DATA
Date Received: 06/12/2018 Patient Sequence Number: 1
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