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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN CONTINUUM SHELL PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNKNOWN CONTINUUM SHELL PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Difficult to Insert (1316); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Blood Loss (2597); Patient Problem/Medical Problem (2688)
Event Date 09/07/2016
Event Type  Death  
Manufacturer Narrative
(b)(4). Concomitant medical products: catalog#: 00875800928 continuum longevity contained liner with locking ring, lot#: 62134601 medical records were not provided, however review of the additional information by a healthcare professional identified: blood loss should be minimal for this procedure, coming only from the layers incised. Excessive bleeding occurs when reaming the acetabulum, broaching the femoral canal, or an incidental puncture of a major artery. Per surgical technique guidance, these events would not have occurred. As the patient had multiple contributing factors and comorbidities, the death is not related to zimmer biomet devices. As the devices being replaced would not come in contact with any bone or major vessels that would lead to excessive bleeding, decline, and death. Dhr was reviewed and no discrepancies relevant to the reported event were found. The root cause of reported death in the complaint was determined to not be related to zimmer biomet devices. However, a definitive root cause for the liner not seating intraoperatively 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: 0001822565-2016-03616.
 
Event Description
It was reported that during a revision procedure, the surgeon had difficulty reducing the hip, positioning the locking ring greater than 1 hour, and patient sustained excessive bleeding resulting in multiple blood transfusions. Due to the patient¿s decline, the surgeon aborted the procedure, secured the locking ring and closed the patient. To replace the ringloc and poly liner, the surgeon makes a deep incision exposing the implants and retracts the large vessels and nerves for adequate exposure. The femoral head is dislocated to expose the head and liner. The liner and locking ring are then disengaged and removed. Postop the patient remained unstable and passed away during the night.
 
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Brand NameUNKNOWN CONTINUUM SHELL
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 Key9907871
MDR Text Key185902623
Report Number0001822565-2020-01211
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 03/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model 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 Received03/27/2020
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 Unkown
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 03/31/2020 Patient Sequence Number: 1
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