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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 54F; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 54F; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Difficult to Insert (1316)
Patient Problem No Code Available (3191)
Event Date 09/07/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).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.Multiple mdr reports were filed for this event; please see associated reports: 0001825034-2018-09709, 0001825034-2018-09712, 0001825034-2018-09714.
 
Event Description
It was reported that during surgery, the liner was unable to engage and lock into the cup.A second liner was attempted with the same results.The surgeon then removed the cup and attempted to implant a second cup.The surgeon was unable to get the fixation that he wanted, the cup was removed and a third cup was implanted.The liner engaged with no issues.The surgery was delayed by 30 minutes.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was able to be confirmed by visual inspection of returned devices.Visual inspection found the shell's inner radius and locking groove to be free of damage.Light scratching and discoloration were observed on rim of the shell.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined with the information provided.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.Unique identifier (udi) #: (b)(4).
 
Event Description
No further event information available at the time of this report.
 
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Brand Name
G7 PPS LTD ACET SHELL 54F
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7965571
MDR Text Key123713271
Report Number0001825034-2018-09711
Device Sequence Number1
Product Code PBI
Combination Product (y/n)N
PMA/PMN Number
PK121874
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 01/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number010000664
Device Lot Number6317104
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/27/2018
Was the Report Sent to FDA? No
Date Manufacturer Received01/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
010000664 6358685 G7 PPS LTD ACET SHELL 54F; 010000858 6356773 G7 NEUTRAL E1 LINER 36MM F; 010000858 6356780 G7 NEUTRAL E1 LINER 36MM F; UNKNOWN HEAD; UNKNOWN STEM; 010000664 6358685 G7 PPS LTD ACET SHELL 54F; 010000858 6356773 G7 NEUTRAL E1 LINER 36MM F; 010000858 6356780 G7 NEUTRAL E1 LINER 36MM F; UNKNOWN HEAD; UNKNOWN STEM
Patient Outcome(s) Required Intervention;
Patient Age44 YR
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