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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP TYPE1 PPS HO 10.0 M T1; PROSTHESIS, HIP

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ZIMMER BIOMET, INC. TPRLC 133 MP TYPE1 PPS HO 10.0 M T1; PROSTHESIS, HIP Back to Search Results
Catalog Number 51-107100
Device Problems Positioning Failure (1158); Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/18/2022
Event Type  malfunction  
Event Description
It was reported the stem could only be placed 10 mm higher than the rasp position.In the surgeon's experience, he had seen them go a few millimeters higher, but this was the first time he had ever seen them 10 mm higher.The surgeon indicated a defect in product design (size).The surgery was completed using a stem implant one size smaller.There were no health consequences or impact to the patient.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
(b)(4).Report source: japan.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.
 
Event Description
No additional event information to report at this time.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4; b5; g3; h2; h3; h6 mechanical (g04) ¿ stem visual inspection found scratches to the taper of the stem but no other visible damage.Dhr was reviewed and no discrepancies related to the reported event were found.The investigation could not verify or identify any evidence of product contribution to the reported problem.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.
 
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Brand Name
TPRLC 133 MP TYPE1 PPS HO 10.0 M T1
Type of Device
PROSTHESIS, 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 Key15464781
MDR Text Key302779562
Report Number0001825034-2022-02190
Device Sequence Number1
Product Code KWA
UDI-Device Identifier00880304513433
UDI-Public(01)00880304513433(17)271126(10)6175976
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K110400
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/17/2022
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 Catalogue Number51-107100
Device Lot Number6175976
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/19/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/29/2022
Initial Date FDA Received09/22/2022
Supplement Dates Manufacturer Received11/16/2022
Supplement Dates FDA Received11/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/26/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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