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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 FP TYPE1 PPS HO 5.0 T1 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. TPRLC 133 FP TYPE1 PPS HO 5.0 T1 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Shipping Damage or Problem (1570)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Report source: (b)(6). Complaint sample was evaluated and the reported event was confirmed. Sterility has been breached for lot 6209552, as the sterile pouch and blister have both been damaged. Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event. The likely condition of the device when it left zimmer biomet is conforming to specification. The root cause of the reported event can be attributed to transit damage.
 
Event Description
It was reported that damaged sterile packaging was identified in the warehouse. No further information is available.
 
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Brand NameTPRLC 133 FP TYPE1 PPS HO 5.0 T1
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 Key12438541
MDR Text Key270283216
Report Number0001825034-2021-02554
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K103755
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number51-101050
Device Lot Number6209552
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/16/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/01/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/19/2018
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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