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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN SCREWS; PROSTHESIS HIP
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ZIMMER BIOMET, INC. UNKNOWN SCREWS; PROSTHESIS HIP Back to Search Results
Device Problems Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Patient Problems Failure of Implant (1924); Pain (1994)
Event Date 01/21/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.Implant date: (b)(6) 2018.Concomitant medical devices: part # unknown / unknown liner/ lot # unknown, part # unknown / unknown head/ lot # unknown, part #unknown / unknown cup/ lot # unknown, part #unknown / unknown stem/ lot # unknown.Reported event was unable to be confirmed.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause could not 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
It was reported patient underwent revision surgery approximately 10 months post implantation due to defective cup and loose screws.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Event Description
No additional event information to report at this time.
 
Manufacturer Narrative
Medical records were provided and reviewed by a health care professional.Patient underwent a hip revision due to pain and loosening of the acetabular cup.X-rays show evidence of loosening of the cup with movement of the acetabular cup in to a vertical position.Intraoperatively, there was evidence of loosening, the liner was still intact and the stem was well fixed.Dhr was unable to be reviewed as the lot number for the device is unknown.The root cause is unable to be determined.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
It was reported that patient underwent a left hip revision surgery approximately one-year post implantation due to groin pain and loosening and migration of the acetabular cup.The head, liner, shell, and screws were replaced without complication.The stem was stable and remained intact.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
 
Manufacturer Narrative
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number: (b)(4).
 
Event Description
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number: (b)(4).
 
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Brand Name
UNKNOWN SCREWS
Type of Device
PROSTHESIS HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key11474342
MDR Text Key239714697
Report Number0001822565-2021-00701
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 11/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/27/2022
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
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEE H10.
Patient Outcome(s) Hospitalization; Required Intervention;
Patient SexMale
Patient Weight114 KG
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