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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS SO 16X152MM T1 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. TPRLC 133 T1 PPS SO 16X152MM T1 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Patient Involvement (2645)
Event Date 06/09/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Report source: (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. 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: 0001825034-2020-02558, 0001825034-2020-02559, 0001825034-2020-02560, 0001825034-2020-02561, 0001825034-2020-02562, 0001825034-2020-02564, 0001825034-2020-02565.
 
Event Description
It was reported that during an investigation of circulated items, several devices were identified as having debris in their sterile packages. No patients were involved. No additional information is available.
 
Manufacturer Narrative
(b)(4). Reported event was confirmed by examination of the devices/photographs. Device history record (dhr) was reviewed and no discrepancies related to the event were found. The root cause of the reported event is likely to be due to transit damage. Evaluation of the returned product/photographs provided confirmed the following: lot #2901608; 3791225; 3090879; 2955965; 3473486; 3458643: debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging inside the sterile barrier. Lot #3383473; 3560787: debris inside the sterile packaging which is consistent with the appearance of the porous coating and foam debris from the foam packaging inside the sterile barrier. If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly. Zimmer biomet will continue to monitor for trends. Upon investigation, it has been determined that the debris in the sterile packaging meets the acceptable criteria and product is conforming to specifications. Event is no longer considered reportable, and initial report should be voided.
 
Event Description
Upon investigation, it has been determined that the debris in the sterile packaging meets the acceptable criteria and product is conforming to specifications. Event is no longer considered reportable, and initial report should be voided.
 
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Brand NameTPRLC 133 T1 PPS SO 16X152MM T1
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key10208915
MDR Text Key197835427
Report Number0001825034-2020-02563
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
K101086
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number51-103160
Device Lot Number3473486
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2020
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

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