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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EPOLY RLC 36MM 10DEG SZ24 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. EPOLY RLC 36MM 10DEG SZ24 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ossification (1428); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060)
Event Date 12/19/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: 650-1057 cer bioloxd option hd 36mm 2934973, 650-1066 cer opt type 1 tpr sleve 0mm 2920992, pt-116056 regen/rnglc+ ltd 56mm sz 24 240160, 010000994 g7 apical hole plug 6102385, 51-108080 tprlc 133 mp t1 pps so 8x101mm 6006745, 103532 ti low profile screw 6. 5x25mm 181420, 106024 ringloc+ replacement ring sz24 304650. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The product location is unknown. 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: 0001825034 - 2020 - 00293 shell, 0001825034 - 2020 - 00294 hole plug, 0001825034 - 2020 - 00295 taper, 0001825034 - 2020 - 00296 screw, 0001825034 - 2020 - 00297 ring.
 
Event Description
It was reported that patient underwent right revision and subsequently, patient underwent another revision a year and a half later due to infection. All components were removed and a cement spacer implanted. Attempts were made to obtain additional information; however, none was available.
 
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Brand NameEPOLY RLC 36MM 10DEG SZ24
Type of DevicePROSTHESIS, 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 Key9608265
MDR Text Key176081242
Report Number0001825034-2020-00298
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100048
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/27/2020
Device Model NumberN/A
Device Catalogue NumberEP-105894
Device Lot Number842180
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/27/2015
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 Treatment Data
Date Received: 01/20/2020 Patient Sequence Number: 1
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