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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN M/L TAPER FEMORAL STEM, SIZE 5 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNKNOWN M/L TAPER FEMORAL STEM, SIZE 5 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Malposition of Device (2616)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/08/2009
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device will not be returned for analysis as the device remains implanted; however, an investigation of the reported event is in progress. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported a patient underwent an initial right total hip arthroplasty for degenerative joint disease. The trial stem size 5 was tested with impingement during rom to the trochanter. The real stem implant #5 was placed which, as expected, didn¿t go down as far as the trial and is standing proud 2 mm. The head, cup, and liner were placed without complications. The final rom was stable and cleared the trochanter very well with no signs of impingement. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameUNKNOWN M/L TAPER FEMORAL STEM, SIZE 5
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key12589338
MDR Text Key276577465
Report Number0001822565-2021-02871
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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

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