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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMUR SCREW STD 18MM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. FEMUR SCREW STD 18MM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Osteopenia/ Osteoporosis (2651)
Event Date 05/03/2022
Event Type  Injury  
Manufacturer Narrative
(b)(4). Report source: (b)(6). Concomitant products: unknown-unknown intellijoint-unknown ; 000-0212- camera drape-unknown ; 000-0163- pelvic screw std 116mm-unknown ; 010000702- g7 bonemaster ltd acet shl 50d- 6938039; 010000856- g7 neutral e1 liner 36mm d- 6782814; 51-113100- tprlc 133 type1 bm so 10. 0- 6987844; 11-363662- 36mm cocr mod hd std- 680410; multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2022 - 01581. Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Device location unknown.
 
Event Description
It was reported after using the intellijoint for a hip replacement the patient experienced a fracture of the greater trochanter. The surgeon believes that the platform in combination with the femoral screw created a stress riser that caused the fracture. Fracture is displaced and contained within the soft tissue so doesn¿t require further intervention at this stage. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameFEMUR SCREW STD 18MM
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer (Section G)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key14546912
MDR Text Key292961936
Report Number0001822565-2022-01622
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number000-0190
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/01/2022
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 Treatment Data
Date Received: 05/31/2022 Patient Sequence Number: 1
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