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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK RINGLOC BIPOLAR CUP PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNK RINGLOC BIPOLAR CUP PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Renal Failure (2041)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Foreign: japan. Source: takuya nakamura, toru yamakawa , junji hori , hisataka goto , akihiko nakagawa , tetsuro takatsu , naoki osamura , atsushi saito , keisuke hagio and kanto mouri. (2021) conjoined tendon preserving posterior approach in hemiarthroplasty for femoral neck fractures: a prospective multicenter clinical study of 322 patients. Journal of orthopaedic surgery. 29 (3) 1-8. Https://doi. Org/10. 1177/23094990211063963. Concomitant medical devices: unknown ringloc bipolar cup; unknown taperloc stem. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-00772. The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported in a journal article that 1 patient experienced renal failure and expired in an unknown time frame postoperatively. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameUNK RINGLOC BIPOLAR CUP
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 Key13953242
MDR Text Key288266443
Report Number0001825034-2022-00773
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberN/I
Device Lot NumberN/I
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/07/2022
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: 03/30/2022 Patient Sequence Number: 1
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