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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRABECULAR METAL MODULAR CUPS PROSTHESIS, HIP

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ZIMMER BIOMET, INC. TRABECULAR METAL MODULAR CUPS PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Malposition of Device
Event Date 12/17/2014
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: 00784802200, m/l taper neck, 60898630. 00801804002, cocr head, 61247014. 00625006525, bone screw, 61238577. 00625006530, bone screw, 61197915. 00630505840, xlpe liner, 61250222. 00771301500, m/l taper stem, 60850474. Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 02286, 0002648920 - 2020 - 00323.

 
Event Description

It was reported that patient underwent a left hip revision approximately 5 years post implantation due to malpositioning of the stem shell, pain and tissue damage. During the surgery, large fluid collection was noted anteriorly with a portion of the cyst cavity sent to pathology. Adverse response to metal debris and local inflammation with chronic irritation of the iliopsoas tendon was also noted. The stem was well fixed and required an extended trochanteric osteotomy to be removed. Attempts have been made and additional information on the reported event is unavailable at this time.

 
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Brand NameTRABECULAR METAL MODULAR CUPS
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 Key10206225
Report Number0001822565-2020-02287
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 06/29/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/29/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2018
Device MODEL NumberN/A
Device Catalogue Number00620205822
Device LOT Number61120973
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 Received06/04/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/02/2008
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 TREATMENT DATA
Date Received: 06/29/2020 Patient Sequence Number: 1
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