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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP TYPE1 PPS SO 11.0 T1 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. TPRLC 133 MP TYPE1 PPS SO 11.0 T1 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Migration (4003)
Patient Problems Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544)
Event Date 02/01/2022
Event Type  Injury  
Event Description
It was reported that patient underwent a left hip revision approximately 3 months post implantation due to pain and difficulty walking. During the procedure, the femoral component was noted to have subsided. The cup and liner remained implanted while the femoral components were removed and replaced. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
(b)(4). Concomitant medical products: 110010246 ¿ g7 shell ¿ 64809428; 30103606 ¿ g7 liner ¿ 65051580; 650-0662 ¿ biolox head ¿ 3033498. (b)(4). Medical records were provided and reviewed by a health care professional. Review of the available records identified the following. Fwb with antalgic gait, rom: 0-90 degrees. Having severe pain and problems walking. Revision of femoral component only due to stem subsidence. Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event. A definitive root cause cannot be determined. 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 NameTPRLC 133 MP TYPE1 PPS SO 11.0 T1
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 Key14734021
MDR Text Key294913227
Report Number0001825034-2022-01431
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 Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number51-106110
Device Lot Number6992251
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2021
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 Treatment Data
Date Received: 06/17/2022 Patient Sequence Number: 1
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