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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL POROUS WITH MULTI HOLES 54 MM; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. SHELL POROUS WITH MULTI HOLES 54 MM; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Loss of or Failure to Bond (1068)
Patient Problem No Code Available (3191)
Event Date 12/31/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: catalog number: 00620205420 lot number: unknown brand name: tm modular cup, catalog number: 00630505036 lot number: 64036969 brand name: xlpe liners, unknown head, unknown stem.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-00352, 0001822565-2020-00353, 0001822565-2020-00354, 0001822565-2020-00355.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.Device not returned for evaluation.
 
Event Description
It was reported that the patient was revised due to recurrent dislocation and acetabular cup loosening.It was noted that a trochanter fracture was noted to have occurred prior to revision.Additional information on the reported event is unavailable.
 
Event Description
No additional event information to report at this time.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; g4; h2; h3; h6 g3: report source australia reported event was confirmed by review of medical records noting patient underwent a previous revision along with two closed reductions for dislocation.Patient continued to dislocate and underwent a hip revision where the cup was found to be loos.A fracture of the greater trochanter was also noted during the procedure.Dhr was unable to be reviewed and 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.
 
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Brand Name
SHELL POROUS WITH MULTI HOLES 54 MM
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9633250
MDR Text Key176453937
Report Number0001822565-2020-00352
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
PMA/PMN Number
K093561
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number00620205420
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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