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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 5.0 MM DIA CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, STERILE

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ZIMMER BIOMET, INC. 5.0 MM DIA CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, STERILE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994)
Event Type  Injury  
Event Description
It was reported the patient underwent a knee procedure in. Subsequently, approximately 2 years post procedure the patient has been experiencing pain with concerns of an allergic reaction. Patient also states she does not feel the bone has ever healed. Original surgery was needed due to a broken leg at which time a rod was implanted.
 
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Additional associated products & mdrs: 47248402250 5. 0 mm dia cortical screw-red fixed angle 3. 5 mm hex head lot# unk mdr: 0001822565-2022-00777. 47248402250 5. 0 mm dia cortical screw-red fixed angle 3. 5 mm hex head lot# unk mdr: 0001822565-2022-00778. 47248402750 5. 0 mm dia cortical screw-red fixed angle 3. 5 mm hex head lot# unk. Mdr: 0001822565-2022-00779. 47248403050 5. 0 mm dia cortical screw - red fixed angle 3. 5 mm hex head lot# unk, mdr: 0001822565-2022-00780. 47249530009 tibial nail-yellow 9. 3 mm dia 30 cm length lot# unk, mdr: 0001822565-2022-00782. 00114704041 4. 0mm cann scr 1/2thr 40mm lg lot# unk, mdr: alliance partner provided devices. Zimmerbiomet does not have reporting responsibility. 00114704041 4. 0mm cann scr 1/2thr 40mm lg lot# unk, mdr: alliance partner provided devices. Zimmerbiomet does not have reporting responsibility.
 
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Brand Name5.0 MM DIA CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD
Type of DeviceORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, STERILE
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 Key13841370
MDR Text Key287558887
Report Number0001822565-2022-00781
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082770
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,Distributor
Reporter Occupation
Type of Report Initial
Report Date 03/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number47248403550
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/21/2022
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

Patient Treatment Data
Date Received: 03/21/2022 Patient Sequence Number: 1
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