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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. REGENEREX RINGLOC HIP SYSTEM LIMITED HOLE ACETABULAR SHELL; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. REGENEREX RINGLOC HIP SYSTEM LIMITED HOLE ACETABULAR SHELL; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Deformation (2976)
Patient Problem No Code Available (3191)
Event Date 08/09/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Foreign country: (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.
 
Event Description
It was reported patient was revised approximately one year post implantation due to fracture of the pe liner and the wear of the cup.The liner, cup and head were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.
 
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.Reported event was confirmed with the device being returned and evaluated.Visual inspection found the inner radius of the shell to have wear consistent with a broken liner.The inner radius is heavily worn.The ends of the ring have become thin and sharp.A large amount of bio debris was observed on the outer radius.The device history records were reviewed and no related deviations/ anomalies were identified that affect the reported event.A definitive root cause cannot be determined with the information 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.
 
Manufacturer Narrative
Upon reassessment of the reported event, the cup was determined to be not reportable.The initial report was forwarded in error and should be voided.The event of the fractured liner will be reported under a uk mfr number, 3002806535-2018-01061.
 
Event Description
Upon reassessment of the reported event, the cup was determined to be not reportable.The initial report was forwarded in error and should be voided.The event of the fractured liner will be reported under a uk mfr number, 3002806535-2018-01061.
 
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Brand Name
REGENEREX RINGLOC HIP SYSTEM LIMITED HOLE ACETABULAR SHELL
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8068702
MDR Text Key127061017
Report Number0001825034-2018-10671
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
PMA/PMN Number
K070369
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 05/13/2020
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
Device Catalogue NumberPT-116052
Device Lot Number716290
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/28/2018
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/15/2018
Initial Date FDA Received11/14/2018
Supplement Dates Manufacturer Received04/02/2019
05/11/2020
Supplement Dates FDA Received04/09/2019
05/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
650-0554BM 3916225 TAPERLOC BMPC 11.0X142MM 12/14; 650-0837 2016041693 DELTA CER FM HD 036/0MM 12/14; EP-083650 3911568 RLOC-X E1 H/W +3MM 50/36MM 23; 650-0554BM 3916225 TAPERLOC BMPC 11.0X142MM 12/14; 650-0837 2016041693 DELTA CER FM HD 036/0MM 12/14; EP-083650 3911568 RLOC-X E1 H/W +3MM 50/36MM 23
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age83 YR
Patient Weight70
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