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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK-HIP-LINER; PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNK-HIP-LINER; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Naturally Worn (2988)
Patient Problems Failure of Implant (1924); Scar Tissue (2060); No Consequences Or Impact To Patient (2199); Osteolysis (2377); Muscle/Tendon Damage (4532)
Event Date 09/30/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: cat# 00660001722, porous fem st 17x153st rt, lot# 56733400, unk-hip-cup, unk-hip-head.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported by patients¿ legal counsel that the patient underwent a right hip revision procedure approximately 20 years post-implantation.Patient was revised due to poly wear.Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
 
Event Description
It was reported the patient was revised approximately 20 years post implantation due to instability of the right hip.During revision significant scarring, osteolysis, synovitis, defect in abductor attachment as well as a pseudocapsule were encountered.No trunnionosis was encountered and the femoral component was well fixed.The acetabular component, head and liner were revised due to liner wear; no complications were noted during procedure.No additional information.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed due to the review of medical records.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues were instability, scaring between the it band, osteolysis debris, pseudocapsule with significant wear as reported.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause could not be determined.The additional information does not change the outcome of the previous investigation.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
UNK-HIP-LINER
Type of Device
PROSTHESIS, 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 Key10574397
MDR Text Key208158034
Report Number0001822565-2020-03282
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 12/02/2021
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? Yes
Device Operator Health Professional
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/31/2020
Initial Date FDA Received09/23/2020
Supplement Dates Manufacturer Received10/29/2020
07/20/2021
11/24/2021
Supplement Dates FDA Received10/30/2020
08/11/2021
12/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEE H10 NARRATIVE.
Patient Outcome(s) Hospitalization; Required Intervention;
Patient SexMale
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