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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR NECK G 12/14 NECK TAPER PROSTHESIS HIP

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ZIMMER BIOMET, INC. MODULAR NECK G 12/14 NECK TAPER PROSTHESIS HIP Back to Search Results
Catalog Number 00784802300
Device Problem Appropriate Term/Code Not Available
Event Type  Injury  
Manufacturer Narrative

(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation as product remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: part # 00625006525, bone screw, lot #: 62466422. Part # 00625006525, bone screw, lot #: 62466422. Part # 00801803202, femoral head, lot #: 62498217. Part # 00771301000, stem, lot #: 60743574. Part # 62025020, shell, lot #: 62064875. Part # 63105032, liner, lot #: 62449618. Part # unknown, femoral head allograft, lot #: unknown. Multiple mdr reports were filed for this event, please see associated reports: 0002648920 -2020 -00277, 0002648920 -2020 -00276, 0001822565 -2020 -01865, 0001822565 -2020 -01884.

 
Event Description

It was reported that during a diagnostic radiology 4 years post implantation that there was bending of the screws of the left superior acetabulum. Slight leg length discrepancy, with the left leg longer than the right (1cm). No revision has been reported to date. Attempts have been made and additional information on the reported event is unavailable at this time.

 
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Brand NameMODULAR NECK G 12/14 NECK TAPER
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
.
warsaw , IN 46582
5745273773
MDR Report Key10091934
Report Number0001822565-2020-01866
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/13/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/27/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number00784802300
Device LOT Number62335380
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 Received07/10/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/10/2013
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: 05/27/2020 Patient Sequence Number: 1
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