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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 14.0 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. TPRLC 133 MP TYPE1 PPS HO 14.0 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Migration (4003)
Patient Problems Failure of Implant (1924); Pain (1994)
Event Date 07/01/2022
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: 110017108 ¿ g7 shell ¿ 64849765; 30123608 ¿ g7 vit e liner ¿ 64849765; 650-1057 ¿ biolox head ¿ 3062933; 650-1067 ¿ biolox taper ¿ 307230. Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported patient underwent a left hip revision approximately 9 months post implantation due to progressive pain. During the surgery, it was noted that the stem appears to have potted due to excessive pps spray at the reduced distal portion of the stem. The stem and head were removed and replaced. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameTPRLC 133 MP TYPE1 PPS HO 14.0
Type of DevicePROSTHESIS, 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 Key15091878
MDR Text Key296468524
Report Number0001825034-2022-01700
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110400
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number51-107140
Device Lot Number6806775
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/23/2020
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 Treatment Data
Date Received: 07/25/2022 Patient Sequence Number: 1
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