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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS HO 16X152MM 2MM T1; PROSTHESIS, HIP

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ZIMMER BIOMET, INC. TPRLC 133 T1 PPS HO 16X152MM 2MM T1; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Date 03/16/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01576.0001825034-2020-01577.
 
Event Description
It was reported that the sterile packaging was damaged.There was no patient involvement as this was found during inventory.
 
Manufacturer Narrative
Following investigation, the sterility of the device was not compromised.This issue is non-reportable.
 
Event Description
Following investigation, the sterility of the device was not compromised.This issue is non-reportable.
 
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Brand Name
TPRLC 133 T1 PPS HO 16X152MM 2MM T1
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9938429
MDR Text Key187880674
Report Number0001825034-2020-01578
Device Sequence Number1
Product Code LPH
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,foreig
Type of Report Initial,Followup
Report Date 04/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2021
Device Model NumberN/A
Device Catalogue Number51-104160
Device Lot Number2473431
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/16/2020
Initial Date FDA Received04/08/2020
Supplement Dates Manufacturer Received04/08/2020
Supplement Dates FDA Received04/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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