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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC XR FP TYPE1 PPS 5X130MM 1; PROSTHESIS, HIP

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ZIMMER BIOMET, INC. TAPERLOC XR FP TYPE1 PPS 5X130MM 1; PROSTHESIS, HIP Back to Search Results
Catalog Number 51-102050
Device Problem Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 03/19/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Concomitant medical products: tprlc 133 fp type1 pps ho 5.0 t1 cat# 51-101050 lot# 3692721, tprlc 133 fp type1 pps ho 5.0 t1 cat# 51-101050 lot# 3590153, tprlc 133 t1 pps ho 17x154mm 4mm t1 cat# 51-104170 lot# 3706660, tprlc xr t1 pps 17x154mm mm t1 cat# 51-105170 lot# 3096162, tprlc 133 fp type1 pps ho 5.0 t1 cat# 51-101050 lot# 2588486.(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: 0001825034-2020-01378, 0001825034-2020-01379, 0001825034-2020-01380, 0001825034-2020-01382, 0001825034-2020-01383.
 
Event Description
It was reported that debris was identified within sterile packaging.There was no patient involvement.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
The complaint sample was evaluated and the reported event was confirmed through visual inspection.The returned packages showed white debris within the sterile packaging.The inserts were damaged such that particles had become detached to float freely within the sterile packaging.The debris was consistent with the foam packaging inside the sterile barrier.The blister seal remained intact and the outer package appeared roughened through handling with no noticeable damage.The device history records were reviewed and no discrepancies were identified.The likely condition of the product when it left zimmer biomet was conforming to specification.Therefore, the root cause of the reported event is likely to be due to transit damage causing the foam packaging to become abraded and shed.The device evaluation found no malfunction and the event did not contribute to injury, therefore this would not be considered a reportable event.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name
TAPERLOC XR FP TYPE1 PPS 5X130MM 1
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9900135
MDR Text Key185903840
Report Number0001825034-2020-01381
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
PMA/PMN Number
K120030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/14/2024
Device Catalogue Number51-102050
Device Lot Number3368426
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/19/2020
Initial Date FDA Received03/30/2020
Supplement Dates Manufacturer Received06/29/2020
Supplement Dates FDA Received06/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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