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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ORTHOPEDIC SALVAGE SYSTEM COMPRESS SPINDLE; PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. UNKNOWN ORTHOPEDIC SALVAGE SYSTEM COMPRESS SPINDLE; PROSTHESIS, KNEE Back to Search Results
Device Problems Inadequacy of Device Shape and/or Size (1583); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Event Description
It was reported that a patient underwent a total knee procedure on an unknown date.It was reported by the surgeon that insufficient inventory was available to implant the appropriate diameter spindle component.Subsequently, on an unknown timeframe post-implantation, the implanted component failed.A revision surgery is pending.Due diligence is in progress for this complaint; to date no further information has been reported.
 
Manufacturer Narrative
(b)(4).D10: medical product: unknown oss cps anchor plug: catalog#ni, lot#ni; unknown oss cps taper adaptor: catalog#ni, lot#ni; unknown oss diaphyseal segment: catalog#ni, lot#ni; unknown oss distal femoral component the product will not be returned to zimmer biomet for investigation, as the product currently remains implanted.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
 
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Brand Name
UNKNOWN ORTHOPEDIC SALVAGE SYSTEM COMPRESS SPINDLE
Type of Device
PROSTHESIS, KNEE
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 Key18934194
MDR Text Key338033720
Report Number0001825034-2024-00768
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 Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/21/2024
Initial Date FDA Received03/19/2024
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
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexPrefer Not To Disclose
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