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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN TAPERLOC STEM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNKNOWN TAPERLOC STEM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Osseointegration Problem (3003); Migration (4003)
Patient Problems Failure of Implant (1924); Pain (1994); Osteopenia/ Osteoporosis (2651)
Event Type  Injury  
Event Description
It was reported the patient experienced femoral loosening at 422 days postop and was subsequently revised. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
(b)(4). Report source: ennin k. A. , elsharkawy k. A. , dasgupta s. , emerson r. H. (2021) cemented femoral stem fixation through the anterior approach has fewer early complications than cementless fixation. Bone joint j 2021;103-b (7 supple b):33¿37. Https://doi. Org/10. 1302/0301-620x. 103b7. Bjj-2020-2230. R1 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.
 
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Brand NameUNKNOWN TAPERLOC STEM
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 Key13719721
MDR Text Key287832369
Report Number0001825034-2022-00515
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2022
Is this an Adverse Event Report? Yes
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 Received03/28/2022
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 NumberNI

Patient Treatment Data
Date Received: 03/10/2022 Patient Sequence Number: 1
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