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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 52E; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 52E; PROSTHESIS, HIP Back to Search Results
Catalog Number 010000663
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 11/05/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: ep-200148- act artic e1 hip brg- 017610, 11-301322-arcos con-474370, 11-301000- mod femoral prox-810870, 110024463- g7 dual mobility liner- 690310, 11-300815- arcos 15x150mm spl tpr- 351720, 00625006535 bone screw 6.5x35 self-tap 63651675, 12-115110- cer bioloxd mod- 2912205, 00223200418- cable cerclage cable- 63989795.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 05335, 0001825034 - 2019 - 05336, 0001825034 - 2019 - 05337, 0001825034 - 2019 - 05339, 0001825034 - 2019 - 05341.Customer has indicated that the product will not be returned to zimmer biomet for investigation, requested but not returned by hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Requested but not returned by hospital.
 
Event Description
It was reported that patient underwent right hip revision.Subsequently, patient underwent third revision approximately one and half years post initial implantation for infection.All devices were removed and replaced with cement spacers.Sales rep indicates no additional information is available.
 
Event Description
Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
 
Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
 
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Brand Name
G7 PPS LTD ACET SHELL 52E
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9384074
MDR Text Key168270124
Report Number0001825034-2019-05338
Device Sequence Number1
Product Code PBI
Combination Product (y/n)N
PMA/PMN Number
K121874
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 03/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number010000663
Device Lot Number6289244
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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