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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI 3 HOLE SHELL 52MM E PROSTHESIS, HIP

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ZIMMER BIOMET, INC. G7 OSSEOTI 3 HOLE SHELL 52MM E PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Difficult to Insert
Event Date 03/18/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: 010000935 ¿ g7 hi-wall liner ¿ 6579225. 010000927 ¿ g7 hi-wall liner- 6351780. Report source: (b)(6). The product is in process of being returned to zimmer biomet for the investigation. Once the investigation has been completed, a follow-up mdr will submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 01602. 0001825034 - 2020 - 01603.

 
Event Description

It was reported that during a hip revision surgery, a cup was implanted without complication. Two different liners were attempted to be implanted without success. A new liner and cup combo were used to complete the surgery with approximately 50 minutes of delay in the surgery. Attempts have been made and additional information on the reported event is unavailable at this time.

 
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Brand NameG7 OSSEOTI 3 HOLE SHELL 52MM E
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 Key9947861
Report Number0001825034-2020-01604
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/13/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/10/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number110010244
Device LOT Number6669360
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 Received05/12/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/31/2019
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: 04/10/2020 Patient Sequence Number: 1
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