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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DELTA CERAMIC OPTION HEAD DIA3 6 HIP PROSTHESIS

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ZIMMER BIOMET, INC. DELTA CERAMIC OPTION HEAD DIA3 6 HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problems Metal Shedding Debris; Naturally Worn
Event Date 02/13/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4) customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: item # ep-108323, e-poly 36 mm +3 hiwall lnr sz23, lot # 821420. Item # 11-103203, taperloc por lat fmrl 9x137, lot # 172200. Item # 650-1064, cer option type 1 tpr sleve -6, lot # 231850. Report source: legal notification. Reported event was confirmed due to medical records received. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Review of complaint history determined that no further action is required as no trends were identified. 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. Multiple reports have been submitted for this event. Please see associated reports: 0001825034-2017-07952, 0001825034-2017-07953, 0001825034-2017-07954.

 
Event Description

It was reported that a patient underwent a revision surgery approximately 3 years post implantation due to a poly liner fracture, metallosis, and femoral head wear. Due to the fracture of the poly liner, the femoral head permeated through the liner causing the head to wear against the cup causing asymmetric location of the femoral head. Attempts have been made, and no further information has been provided.

 
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Brand NameDELTA CERAMIC OPTION HEAD DIA3 6
Type of DeviceHIP PROSTHESIS
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 Key7441060
Report Number0001825034-2018-02791
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/19/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/18/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number650-1057
Device LOT Number411390
OTHER Device ID NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/31/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/16/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/06/2014
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: 04/18/2018 Patient Sequence Number: 1
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