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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP TYPE1 PPS HO 14.0; PROSTHESIS, HIP

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ZIMMER BIOMET, INC. TPRLC 133 MP TYPE1 PPS HO 14.0; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Impaired Healing (2378)
Event Date 02/20/2012
Event Type  Injury  
Manufacturer Narrative
(b)(4).650-1057, cer bioloxd option hd 36mm, unknown; unknown, unknown mh ringloc shell, unknown; unknown, unknown e1 maxrom liner, unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-06151, 0001825034-2018-06150, 0001825034-2018-06148.Customer has indicated that the product will not be returned to zimmer biomet for investigation, [remains implanted].The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported a patient's left hip underwent i&d due to nonhealing surgical wound approximately one month post implantation.No further information is available at this time.
 
Manufacturer Narrative
Upon reassessment of the complaint it was determined that the complaint was already reported on 0001825034-2015-00947.The initial report submitted should be voided.
 
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Brand Name
TPRLC 133 MP TYPE1 PPS HO 14.0
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7753676
MDR Text Key116207618
Report Number0001825034-2018-06152
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
PK110400
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Type of Report Initial,Followup
Report Date 09/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number51-107140
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/12/2018
Initial Date FDA Received08/06/2018
Supplement Dates Manufacturer Received08/31/2018
Supplement Dates FDA Received09/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age60 YR
Patient Weight116
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