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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK TM 64MM CUP PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNK TM 64MM CUP PROSTHESIS, HIP Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Hematoma (1884); Impaired Healing (2378)
Event Date 08/07/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: part # unknown / unk 36+10. 5 femoral head/ lot # unknown. Part #unknown / unk liner/ lot # unknown. Part #unknown / unk screws/ lot # unknown/ quantity 7. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-00225, 0001822565-2022-00229, 0001822565-2022-00230.
 
Event Description
It was reported that patient underwent total left hip arthroplasty approximately 4 years ago. Subsequently, the patient underwent two separate revisions of the acetabular and femoral components due to loosening. Approximately three weeks after the second revision, the patient experienced a postop hematoma which was surgically debrided without complication. Intra-op cultures grew staphylococcus epidermis indicating a superficial infection. The debridement did not extend into the joint, and no product was exchanged. After changing the postop antibiotics, the patient healed without further complications. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameUNK TM 64MM 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 Key13391605
MDR Text Key286452347
Report Number0001822565-2022-00226
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091508
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,Distributor
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/26/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/31/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/22/2022
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
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 01/31/2022 Patient Sequence Number: 1
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