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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UKNOWN 32+0 HEAD PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UKNOWN 32+0 HEAD PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problems Pain (1994); Scar Tissue (2060); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)
Event Date 05/23/2022
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant products: unknown zimmer 50 cup, unknown 10 m-l taper stem, unknown 32 liner. Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2022 - 01543.
 
Event Description
It was patient underwent initial hip arthroplasty. Subsequently, the patient has been indicated for revision due to possible metallosis, osteolysis, and hamstring tear; however, no revision has been reported to date. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameUKNOWN 32+0 HEAD
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 Key14479763
MDR Text Key292471718
Report Number0001822565-2022-01542
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 Consumer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2022
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 Received08/04/2022
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: 05/23/2022 Patient Sequence Number: 1
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