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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PSN TIB STM 5 DEG SZ F L PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. PSN TIB STM 5 DEG SZ F L PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Failure of Implant (1924); Loss of Range of Motion (2032); Scar Tissue (2060)
Event Date 05/12/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: 42502607001 - psn fem cr cmt ccr std sz 11 l - 64706173. 42512200510 - articular surface fixed bearing ultracongruent (uc) left 10 mm height - 64633622. Report source: foreign country: (b)(6). The customer has indicated that the product will not be returned to zimmer biomet for investigation as it was not returned by the patient. 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: 0001822565-2021-01475.
 
Event Description
It was reported the patient underwent an initial knee arthroplasty. The patient then underwent an arthroscopy approximately 4 months post-implantation. Subsequently, the patient was revised 4 months later due to loosening as there was incomplete fixation and the femur was also extended. Attempts have been made and no further information has been provided.
 
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Brand NamePSN TIB STM 5 DEG SZ F L
Type of DevicePROSTHESIS, KNEE
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 Key11929674
MDR Text Key254007715
Report Number0001822565-2021-01476
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K172524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number42532007501
Device Lot Number64760552
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/09/2020
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: 06/03/2021 Patient Sequence Number: 1
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