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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL POROUS WITH CLUSTER HOLES 56 MM O.D.; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. SHELL POROUS WITH CLUSTER HOLES 56 MM O.D.; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Medical Device Problem Code Unstable (1667)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 11/05/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: 00811400100 64631370 femoral stem; 00801803603 64484761 femoral head; 00630505636 64153745 liner.Foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation; due to the device was discarded.The investigation is in process.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: 0002648920 - 2020 - 00497, 0002648920 - 2020 - 00498, 0001822565 - 2020 - 03836.
 
Event or Problem Description
It was reported patient underwent initial hip arthroplasty.Subsequently, the patient was revised approximately one month post implantation due to dislocation and instability.Additional information on the reported event is unavailable.
 
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
 
Event or Problem Description
Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
 
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Brand Name
SHELL POROUS WITH CLUSTER HOLES 56 MM O.D.
Common Device Name
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key10844654
Report Number0001822565-2020-03835
Device Sequence Number3799127
Product Code LPH
UDI-Device Identifier00889024118157
UDI-Public(01)00889024118157
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K934765
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 03/17/2021
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
Operator of Device Health Professional
Device Model NumberN/A
Device Catalogue Number00620005622
Device Lot Number63833276
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 11/05/2020
Supplement Date Received by Manufacturer03/16/2021
Initial Report FDA Received Date11/16/2020
Supplement Report FDA Received Date03/19/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
If action reported to FDA under 21 USC 360i(g), list
FDA-assigned Recall Number or include a statement		N/A
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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