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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR MP T1 PPS 13X111MM; PROTHESIS, HIP

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ZIMMER BIOMET, INC. TPRLC XR MP T1 PPS 13X111MM; PROTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/29/2023
Event Type  malfunction  
Manufacturer Narrative
(b)(4).G2: foreign: country: (b)(6).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: 0001825034-2023-02069 0001825034-2023-02070 0001825034-2023-02072 0001825034-2023-02073.
 
Event Description
It was reported that during inspection of stock, the sterile pouch was found damaged.No additional information is available.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Visual evaluation of the returned product identified damage to the sterile packaging (blister).For lot# 6726112 sterility has been compromised.The sterility for the remaining lots has not been breached.The reported event has been confirmed by evaluation of the returned product.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.The condition of the device when it left zimmer biomet is considered conforming to specification.The root cause of the reported event can be attributed to transit damage and a packaging design issue.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.
 
Event Description
No further information is available at the time of this report.
 
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Brand Name
TPRLC XR MP T1 PPS 13X111MM
Type of Device
PROTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
p.o. box 587
warsaw IN 46581
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
p.o. box 587
warsaw IN 46581
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key17685840
MDR Text Key322672162
Report Number0001825034-2023-02071
Device Sequence Number1
Product Code LPH
UDI-Device Identifier00880304517325
UDI-Public(01)00880304517325(17)310124(10)6985718
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K120030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/19/2023
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 Model NumberN/A
Device Catalogue Number51-145130
Device Lot Number6985718
Was Device Available for Evaluation? Device Returned to Manufacturer
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/29/2023
Initial Date FDA Received09/05/2023
Supplement Dates Manufacturer Received12/13/2023
Supplement Dates FDA Received12/19/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/24/2021
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
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