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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FREEDOM CONSTR. LINER +5 SZ 23; PROSTHESIS, HIP

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ZIMMER BIOMET, INC. FREEDOM CONSTR. LINER +5 SZ 23; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/30/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Product has been received by 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 the initial left hip procedure the constraint ring popped off the liner during impaction into the acetabular cup.The procedure was completed with another liner.Attempts have been made and additional information on the reported event is unavailable.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned device showed deep gouge on the scallop and inner articulating surface.The liner also showed indentations on the outer surface and on the ring groove area.The constrained ring did show small scratches which was likely from the usage and there is no other significant damage present on the ring.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.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.
 
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Brand Name
FREEDOM CONSTR. LINER +5 SZ 23
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 Key7109312
MDR Text Key94965662
Report Number0001825034-2017-10966
Device Sequence Number1
Product Code KWZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK030047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date08/11/2022
Device Model NumberN/A
Device Catalogue Number11-107022
Device Lot Number650650
Other Device ID NumberSEE H10 NARRATIVE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/15/2017
Initial Date FDA Received12/12/2017
Supplement Dates Manufacturer Received07/19/2018
Supplement Dates FDA Received08/09/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/11/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Age66 YR
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