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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP T1 PPS SO 7X99MM; PROTHESIS, HIP

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ZIMMER BIOMET, INC. TPRLC 133 MP T1 PPS SO 7X99MM; PROTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Difficult to Insert (1316)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/26/2024
Event Type  malfunction  
Manufacturer Narrative
(b)(4).D10: cat# unk lot# unk unknown size 7 broach.Customer has indicated that the product remains implanted and will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the stem implant was oversized by at least one complete size compared to the broach.The surgeon broached multiple times, with the broach going on very easily but the stem sat about 5 or 6mm proud.The surgeon had to drop from a standard to a -6 neck length, and the stem was implanted.It was determined to likely be an implant issue since there hasn't been an issue with the broach in previous cases.Surgical technique was utilized.There were no patient conditions or anatomy that contributed to the event.There was no patient impact and no surgical delay.No additional information available.
 
Event Description
No further event information is available at the time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information and corrected.The following section was corrected: d4.Product will not be returned for analysis.However, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.
 
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Brand Name
TPRLC 133 MP T1 PPS SO 7X99MM
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 Key18887042
MDR Text Key337455040
Report Number0001825034-2024-00692
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,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/08/2024
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 Number51-108070
Device Lot Number748515
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/03/2024
Initial Date FDA Received03/12/2024
Supplement Dates Manufacturer Received04/30/2024
Supplement Dates FDA Received05/13/2024
Was Device Evaluated by Manufacturer? No
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
Patient SexMale
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