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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 48C; PROSTHESIS, HIP

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ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 48C; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Difficult To Position (1467)
Patient Problem No Information (3190)
Event Date 04/16/2018
Event Type  Injury  
Manufacturer Narrative
Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Mfr for associated product, bone screw: 0002648920-2018 -00408.
 
Event Description
It was reported that upon inserting screw into cup, the screw went all the way through the holes.Surgeon removed the devices and completed the surgery with new devices.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The returned device showed threads of the screw hole of the shell are damaged.Due to the damage both go and no-go thread gage did not mate with the screw hole of the shell.The head of the screw is heavily damaged and appears to have indications of the shell thread gouged into it.Due to the screw head damage, the screw did not pass through when the screw is straight in the hole but when it is held at an angle it passes through.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.
 
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Brand Name
G7 PPS LTD ACET SHELL 48C
Type of Device
PROSTHESIS, 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 Key7513658
MDR Text Key108228668
Report Number0001825034-2018-03321
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK121874
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberN/A
Device Catalogue Number010000661
Device Lot Number6062452
Other Device ID Number(01) 00880304524200
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/16/2018
Initial Date FDA Received05/15/2018
Supplement Dates Manufacturer Received05/30/2018
Supplement Dates FDA Received06/01/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/14/2017
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 Sequence Number1
Treatment
00625006520 / 63989403 SCREW
Patient Outcome(s) Required Intervention;
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