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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZB 12/14 COCR FRDM 36MM X +6 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. ZB 12/14 COCR FRDM 36MM X +6 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Hematoma (1884); Loss of Range of Motion (2032); Scar Tissue (2060); Joint Dislocation (2374); Muscle/Tendon Damage (4532)
Event Date 10/28/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: ref 110010245 lot 64866560 shell. Ref 00-7850-013-00 lot 63992895 femoral stem. Ref 010000984 lot 6993137 g7 freedom const e1 lnr 36mm f. The device will not be returned for analysis, as the device was discarded; 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 the patient underwent initial left hip hemiarthroplasty. The patient was converted to a total hip arthroplasty approximately 3 years later. The patient underwent head and liner exchange approximately 6 months later to recurrent dislocations. The patient was revised again approximately 3 weeks later due to recurrent dislocations and psoas tendon rupture. The head and liner were exchanged without complication. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameZB 12/14 COCR FRDM 36MM X +6
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 Key13343632
MDR Text Key284375759
Report Number0001822565-2022-00185
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K183457
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number802403605
Device Lot Number3018288
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/07/2020
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: 01/25/2022 Patient Sequence Number: 1
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