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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS SO 16X152MM; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. TPRLC 133 T1 PPS SO 16X152MM; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Date 12/03/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the patient underwent initial left total hip arthroplasty.Subsequently, patient had a possible i & d approximately 1 month later.The patient was revised approximately 2 months post implantation due to deep infection.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Event Description
It was reported that the patient underwent initial left total hip arthroplasty.Subsequently, the patient underwent stage 1 revision due to infection approximately 1 month later.Stage 2 reimplantation occurred approximately 3 months later.No further event information available at the time of this report.
 
Manufacturer Narrative
D10: explanted product stage 1: acetabular cup ¿ 110010247, lot 6815876 acetabular liner ¿ 30123607, lot 64802478 femoral head component ¿ 6500661, lot 3030565 femoral stem ¿ 51103160, lot 6454785 explanted product stage 2: djo bone cement ref 600-15-000 lot 939d1d0042 g7 liner ref 30123607 lot 64926920 depuy head and spacer.
 
Event Description
Upon reassessment of the reported event, the device was determined to be not reportable.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection.The initial report was forwarded in error and should be voided.
 
Manufacturer Narrative
Upon reassessment of the reported event, the device was determined to be not reportable.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection.The initial report was forwarded in error and should be voided.
 
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Brand Name
TPRLC 133 T1 PPS SO 16X152MM
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key11382123
MDR Text Key233730087
Report Number0001825034-2021-00586
Device Sequence Number1
Product Code KWL
UDI-Device Identifier00880304489691
UDI-Public(01)00880304489691
Combination Product (y/n)N
PMA/PMN Number
K101086
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,study
Type of Report Initial,Followup,Followup
Report Date 05/17/2021
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? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number51-103160
Device Lot Number6454785
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/05/2021
Initial Date FDA Received02/25/2021
Supplement Dates Manufacturer Received03/31/2021
05/14/2021
Supplement Dates FDA Received04/20/2021
05/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
ZIMMER HEAD CAT#6500661 LOT#3030565; ZIMMER LINER CAT#30123607 LOT#64802478; ZIMMER HEAD CAT#6500661 LOT#3030565; ZIMMER LINER CAT#30123607 LOT#64802478
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Weight109
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