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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL WITH CLUSTER HOLES POROUS 48 MM O.D. SIZE GG FOR USE WITH GG LINERS PROSTHESIS, HIP

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ZIMMER BIOMET, INC. SHELL WITH CLUSTER HOLES POROUS 48 MM O.D. SIZE GG FOR USE WITH GG LINERS PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Difficult to Insert (1316); Difficult To Position (1467)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/02/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: 00875200832, liner elevated rim 32 mm i. D. Size gg for use with 48 mm o. D. Size gg shell, 63746657. (b)(6). Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-03545. Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that during the left total hip arthroplasty, after implanting the shell, the liner couldn't be seated in the shell. Subsequently the surgeon completed the surgery with a different shell and liner. Delay of 40 minutes was noted. Attempts have been made and additional information on the reported event is unavailable.

 
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Brand NameSHELL WITH CLUSTER HOLES POROUS 48 MM O.D. SIZE GG FOR USE WITH GG LINERS
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 Key7664523
MDR Text Key113251998
Report Number0001822565-2018-03546
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberPK151448
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/05/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/05/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number00875304801
Device LOT Number63716493
OTHER Device ID Number(10) 00889024150133
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/13/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/04/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/05/2017
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: 07/05/2018 Patient Sequence Number: 1
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